Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
252
Countries
8
Sites
39
Parkinson’s Disease
To assess the efficacy of BIA 28-6156 in delaying meaningful clinical motor progression in subjects with Parkinson’s disease (PD) who have a pathogenic variant in the GBA1 gene (GBA-PD) as assessed by the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and Part III
Key facts
- Sponsor
- Bial R&D Investments S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 21 Jul 2023 → 3 Apr 2026
- Decision date (initial)
- 2023-06-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- BIAL R&D Investments S.A.
External identifiers
- EU CT number
- 2022-501783-18-00
- ClinicalTrials.gov
- NCT05819359
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Others, Pharmacodynamic
To assess the efficacy of BIA 28-6156 in delaying meaningful clinical motor progression in subjects with Parkinson’s disease (PD) who have a pathogenic variant in the GBA1 gene (GBA-PD) as assessed by the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and Part III
Secondary objectives 3
- 1. To assess the efficacy of BIA 28-6156 in delaying meaningful clinical motor progression in subjects with GBA-PD as assessed by MDS-UPDRS Part III
- 2. To assess the efficacy of BIA 28-6156 in slowing disease progression and functional impairment in subjects with GBA-PD as assessed by the MDS-UPDRS, bradykinesia subscore of the MDS-UPDRS Part III, the modified Hoehn and Yahr scale, the Parkinson’s Disease Cognitive Rating Scale (PD-CRS), the 39-Item Parkinson’s Disease Questionnaire (PQD-39), the EQ-5D-5L (EuroQol 5 Dimension 5 Level) scale, the Clinical Global Impression - Change (CGI-C) scale, the Patient Global Impression - Change (PGI-C) scale, the Clinical Global Impression – Severity (CGI-S) scale, and the Patient Global Impression – Severity (PGI-S) scale
- 3. Further Exploratory, Safety, Pharmacodynamic, Pharmacokinetics and Pharmacogenomic Objectives are visible in the study protocol
Conditions and MedDRA coding
Parkinson’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Study design This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]), Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, tolerability, pharmacodynamics, and PK of 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) in approximately 237 subjects (79 subjects per treatment group) with genetically confirmed GBA-PD; a clinical diagnosis of PD for at least 1 year, and for no longer than 7 years before initiation of screening, as confirmed by a neurologist using the Movement Disorder Society (MDS) Criteria for Parkinson’s Disease; a modified Hoehn and Yahr score ≤2.5; and a score of ≥22 on the Montreal Cognitive Assessment (MoCA). Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and will continue to receive their usual PD medications throughout the study.
Part A (Genetic Screening) will consist of one visit to identify individuals with a PD risk-associated variant in the GBA1 gene for potential enrollment into Part B (Double-Blind Treatment) of the study.
Part B will consist of a Screening Period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met (up to 5 weeks [35 days]), a Double-Blind Treatment Period of up to 78 weeks, and a 30-day (4 weeks) Safety Follow-up Period
Subjects who continue to meet the study eligibility criteria at the Baseline visit will be randomized in a 1:1:1 allocation ratio to:
• BIA 28-6156: 10 mg/day (1 tablet/day)
• BIA 28-6156: 60 mg/day (1 tablet/day)
• Matching placebo (1 tablet/day)
|
Randomised Controlled | Double | [{"id":143954,"code":2,"name":"Investigator"},{"id":143953,"code":4,"name":"Analyst"},{"id":143952,"code":1,"name":"Subject"},{"id":143951,"code":3,"name":"Monitor"}] | BIA 28-6156: 10 mg/day: 79 subjects per treatment group BIA 28-6156: 60 mg/day: 79 subjects per treatment group Matching placebo: 79 subjects per treatment group |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- 1. Part A (Genetic Screening): The subject is ≥35 and ≤80 years of age at the time of informed consent.
- 10. Part B (Double-Blind Treatment): The subject has been on stable doses of PD medications (as listed in Table 6) for at least 30 days (at least 60 days for rasagiline) before initiation of screening in Part B (Double-Blind Treatment).
- 11. Part B (Double-Blind Treatment): The subject is able to comply with the study restrictions and is willing and able to use a Smartphone application and to wear a Smartwatch to measure PD-related motor signs for the duration of the study.
- 12. Part B (Double-Blind Treatment): The subject has a body mass index (BMI) of 18 to 40 kg/m2 .
- 13. Part B (Double-Blind Treatment): If a sexually active man or a woman of childbearing potential, the subject agrees to use highly effective birth control (Appendix 3 of the study protocol) or to remain abstinent during the trial and for 30 days after the last dose of IMP. Acceptable (highly effective) methods of contraception for this study include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant); intrauterine device or system; complete abstinence from sexual intercourse if this is the subject's usual and preferred lifestyle; or sexual partner with surgical sterilization (e.g., tubal ligation, hysterectomy and/or bilateral oophorectomy, vasectomy).
- 2. Part A (Genetic Screening): The subject has a clinical diagnosis of PD for at least 1 year and for no longer than 7 years before initiation of screening (for Part A), as confirmed by a neurologist using the MDS Criteria for Parkinson’s Disease (Postuma, 2015).
- 3. Part A (Genetic Screening): The subject has a modified Hoehn and Yahr score ≤2.5.
- 4. Part A (Genetic Screening): The subject is receiving symptomatic treatment for PD.
- 5. Part A (Genetic Screening): The subject is capable of giving signed informed consent, which includes understanding the purpose and risks of the study, compliance with the requirements and restrictions that are listed in the ICF and this protocol, and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- 6. Part B (Double-Blind Treatment): The subject is capable of giving signed informed consent, which includes understanding the purpose and risks of the study, compliance with the requirements and restrictions that are listed in the ICF and in this protocol, and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- 7. Part B (Double-Blind Treatment): The subject has a known GBA-PD risk-associated variant (as determined in Part A [Genetic Screening] in this study). A list of permissible GBA1 mutations is presented in Appendix 4 of the study protocol.
- 8. Part B (Double-Blind Treatment): The subject has a score ≥22 on the MoCA scale.
- 9. Part B (Double-Blind Treatment): The subject does not have moderate motor complications as assessed by a score ≥3 in any of the subitems of the MDS-UPDRS Part IV.
- 14. Part B (Double-blind treatment): The subject does not have clinically significant psychosis in the clinical judgment of the investigator.
Exclusion criteria 27
- 1. Part A (Genetic Screening): Individuals who do not satisfy the inclusion criteria for Part A (Genetic Screening; Section 5.2.1 of study protocol) will be excluded.
- 10. Part B (Double-Blind Treatment): The subject is currently pregnant, is planning pregnancy within the timeframe of the study, or is breastfeeding.
- 11. Part B (Double-Blind Treatment): The subject is using a strong CYP3A4 modulator at the time of screening for Part B (Double-Blind Treatment). CYP3A4 strong inhibitors and inducers include, but are not limited to, the medications that are listed in Appendix 4 of the study protocol.
- 12. Part B (Double-Blind Treatment): The subject is using a breast cancer resistance protein (BCRP) substrate (e.g., pravastatin, rosuvastatin, glyburide) at the time of screening for Part B (Double-Blind Treatment). The BCRP substrate medications that are considered exclusionary (based on concomitant use with BCRP inhibitors, as provided in the Summary of Product Characteristics [SmPC], for the medication) are included, but are not limited to, the medications that are listed in Appendix 4 of the study protocol.
- 13. Part B (Double-blind treatment): The subject has used any of the following medications within 60 days before Baseline: typical or atypical antipsychotics (including, but not limited to, clozapine, pimavanserin, olanzapine, quetiapine, risperidone, and aripiprazole); metoclopramide; prochlorperazine; methyldopa; tetrabenazine; deutetrabenazine; valbenazine; or reserpine or a prior history or continuation or initiation during the study of ambroxol at doses >120 mg/day.
- 14. Part B (Double-Blind Treatment): The subject has received a vaccination within 14 days before administration of the first dose of IMP.
- 15. Part B (Double-Blind Treatment): The subject has a prior history of or there is a plan to conduct DBS, lesional procedures, (i.e., thalamotomy), or focused ultrasound; to initiate gene therapy treatment for PD; or to initiate use of any formulation of intestinal infusion or continuous subcutaneous infusion of PD medications.
- 16. Part B (Double-Blind Treatment): The subject is currently participating in or has participated in an investigational drug study within 3 months or 5 half-lives, whichever is longer; in a therapeutic device study within 3 months before the first dose of IMP; or has previously participated in a gene therapy trial. Concurrent participation in an observational study is acceptable.
- 17. Part B (Double-Blind Treatment): The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus 1 (HIV-1) or 2 (HIV-2) at screening. If reflex testing for hepatitis B or HCV DNA is negative, the subject may be eligible for the study.
- 18. Part B (Double-Blind Treatment): The subject has renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min at screening.
- 19. Part B (Double-Blind Treatment): The subject has cirrhosis (Child-Pugh A, B, or C) or any of the following laboratory values at screening: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) or bilirubin >2 × ULN except if the subject has known or suspected Gilbert’s disease.
- 2. Part B (Double-Blind Treatment): The subject has GD, as defined by clinical signs and symptoms (i.e., hepatosplenomegaly, cytopenia, skeletal disease), and/or a medical history of marked deficiency of GCase activity compatible with GD.
- 20. Part B (Double-Blind Treatment): The subject has a QTcF (QT interval corrected for heart rate by Fridericia’s method) value >450 msec if male or >470 msec if female at screening.
- 21. Part B (Double-Blind Treatment): The subject provides a positive response on Question 4 or 5 of the C-SSRS based on the last 6 months or, in the opinion of the investigator, presents a serious risk of suicide at screening.
- 22. Part B (Double-Blind Treatment): The subject had a positive SARS-CoV-2 test (any type) result within the 30 days before signing informed consent for Part B (Double-Blind Treatment) or has 2 or more current symptoms (e.g., sore throat, cough, fever) at the same time that are consistent with COVID-19 infection (not tested) in the opinion of the investigator.
- 23. Part B (Double-Blind Treatment): The subject has a clinical history that is consistent with a previous COVID-19 infection and has not recovered fully, maintaining nonspecific symptoms like, for example, fatigue, shortness of breath, difficulty concentrating, sleep disorders, fever, anxiety, and depression.
- 24. Part B (Double-Blind Treatment): The subject has previously received BIA 28-6156 or has a known allergy or hypersensitivity to BIA 28-6156 or any components of the formulation.
- 25. Part B (Double-Blind Treatment): The subject is an unsuitable candidate to receive BIA 28-6156 or is unable or unlikely to comply with the dosing schedule or study evaluations in the judgment of the investigator.
- 3. Part B (Double-Blind Treatment): The subject is homozygous for a GBA1 pathogenic variant that is known to be associated with GD or compound heterozygous for 2 alleles that are known to be associated with GD (N370S, D409H, H255Q, D140H, G202R, L324P, I260T, L444P, A190T, R120W).
- 4. Part B (Double-Blind Treatment): The subject carries a known PD-associated LRRK2 pathogenic variant. A list of exclusionary LRRK2 pathogenic variants is provided in Appendix 4 of the study protocol.
- 5. Part B (Double-Blind Treatment): The subject has atypical or secondary parkinsonism by medical history or in the opinion of the investigator. Atypical parkinsonism includes, but is not limited to, diagnoses of progressive supranuclear palsy, cortico-basal syndrome, and multiple system atrophy. Secondary parkinsonism includes drug-induced, toxin-induced, postinfectious, posttraumatic, or vascular parkinsonism.
- 6. Part B (Double-Blind Treatment): The subject has a history of (within 60 days before initiation of screening) or has planned upcoming major surgery that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would pose an unacceptable risk to the subject in the opinion of the investigator.
- 7. Part B (Double-Blind Treatment): The subject has any active or chronic disease or condition other than PD that could interfere with, or for which the treatment might interfere with, the conduct of the study or pose an unacceptable risk to the subject in the opinion of the investigator based on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests. Minor deviations of laboratory values from the normal range may be acceptable if judged by the investigator to have no/minor clinical relevance.
- 8. Part B (Double-Blind Treatment): The subject has a recent history (last 6 months) of abuse of addictive substances (alcohol, illegal substances), currently uses >21 units of alcohol per week, or is a regular recreational user of sedatives, hypnotics, tranquillizers, or any other addictive agent in the opinion of the investigator.
- 9. Part B (Double-blind treatment): The subject has a positive test for drugs of abuse at screening or before administration of the first dose of IMP that the investigator judges as clinically relevant. Use of cannabinoids is not exclusionary if the subject agrees to abstain from using cannabinoids within 12 hours before study visits. A positive drug screen that is attributed to an allowed prescription, including medicines containing THC, or over-the-counter (OTC) drug is not exclusionary but should be agreed with the medical monitor
- 26. Part B (Double-blind treatment): The subject is a member of a protected/vulnerable population, defined as persons who are pregnant, parturient, or breastfeeding; minors; persons who are deprived of liberty; persons who are under psychiatric hospital care; persons who are admitted to a health or social institution for purposes other than research; adults who are under legal protection or who are unable to express their consent; persons who are in an emergency situation and are unable to express their prior consent; and persons are who are non-affiliated or a non-beneficiary of a social security system [This does not apply to persons in the United States without health insurance].
- 27. Part B (Double-blind treatment): The subject is a relative of the investigator or sponsor or the relative of an employee of the sponsor
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living, as assessed by ≥2-point increase in the MDS-UPDRS Part II score and no improvement (i.e., difference of zero or higher) in the Part III score
Secondary endpoints 1
- • Time from baseline to clinically meaningful progression on motor signs of the disease, as assessed by a ≥5-point increase in the MDS-UPDRS Part III score (key secondary endpoint) • Further Secondary, Exploratory, Safety, Pharmacodynamic, Pharmacokinetics and Pharmacogenomic Endpoints are visible in the study protocol
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10145115 · Product
- Active substance
- 57-DIMETHYL-N-1R4R-4-PENTYLOXYCYCLOHEXYLPYRAZOLO15-APYRIMIDINE-3-CARBOXAMIDE
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 4680 mg milligram(s)
- Max treatment duration
- 78 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIAL - R&D INVESTMENTS, S.A.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10145114 · Product
- Active substance
- 57-DIMETHYL-N-1R4R-4-PENTYLOXYCYCLOHEXYLPYRAZOLO15-APYRIMIDINE-3-CARBOXAMIDE
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 780 mg milligram(s)
- Max treatment duration
- 78 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIAL - R&D INVESTMENTS, S.A.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bial R&D Investments S.A.
- Sponsor organisation
- Bial R&D Investments S.A.
- Address
- Avenida Da Siderurgia Nacional, Sao Mamede Do Coronado Sao Mamede Do Coronado
- City
- Trofa
- Postcode
- 4745-457
- Country
- Portugal
Scientific contact point
- Organisation
- Bial R&D Investments S.A.
- Contact name
- Luís Magalhães
Public contact point
- Organisation
- Bial R&D Investments S.A.
- Contact name
- Raquel Costa
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Clinical Ink Inc. ORG-100042433
|
Horsham, United States | Other |
| Certara USA Inc. ORG-100042611
|
Princeton, United States | Other |
| Bioclinica Inc. ORL-000004205
|
Philadelphia, United States | Interactive response technologies (IRT) |
| Merative UK Limited ORG-100045594
|
Edinburgh, United Kingdom | E-data capture |
| Acm Medical Laboratory Inc. ORG-100042792
|
Rochester, United States | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Worldwide Clinical Trials ORG-100030991
|
Grad Zagreb, Croatia | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Interactive response technologies (IRT), Code 5, Code 8 |
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
| Voute ORG-100031408
|
Montpellier, France | Other |
| Fulgent Genetics Inc. ORG-100047477
|
El Monte, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
Locations
8 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 6 |
| Germany | Ended | 8 | 5 |
| Italy | Ended | 18 | 9 |
| Netherlands | Ended | 6 | 2 |
| Poland | Ended | 10 | 3 |
| Portugal | Ended | 8 | 5 |
| Spain | Ended | 31 | 7 |
| Sweden | Ended | 3 | 2 |
| Rest of world
Canada, United Kingdom, United States
|
— | 156 | — |
Investigational sites
Centre Hospitalier Universitaire De Rennes
Service de Neurologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Toulouse
CIC, Place Du Docteur Joseph Baylac, 31000, Toulouse
Centre Hospitalier Universitaire De Nice
Service de Neurologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Nimes
Service de Neurologie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Universitaire De Nantes
CIC, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Assistance Publique Hopitaux De Paris
CIC Neurosciences, 43 Boulevard De L Hopital, 75013, Paris
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
Zentrum für Parkinson-Syndrome und Bewegungsstoerungen, Klinikstrasse 16, Harleshausen, Kassel
Klinikum der Universitaet Muenchen AöR
Neurologische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Giessen und Marburg GmbH
Klinik für Neurologie, Baldingerstrasse 1, 35043, Marburg
Gertrudis Klinik Biskirchen
Parkinson-Zentrum, Karl-Ferdinand-Broll-Straße 2, 35638, Leun-Biskirchen
Kliniken Beelitz GmbH
Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson, Straße nach Fichtenwalde 16, 14547, Beelitz-Heilstätten
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurology, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Neuroscience e salute mentale, Via Francesco Sforza 35, 20122, Milan
IRCCS Foundation Istituto Neurologico Carlo Besta
U.O. Neurologia I – Malattia di Parkinson e disturbi del movimento, Via Giovanni Celoria 11, 20133, Milan
Azienda Ospedale-Universita Padova
Clinica Neurologica - U.O.C Neurologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Unita Sanitaria Locale Di Bologna
Dipartimento di Scienze Biomediche e Neuromotorie, Via Altura 3, 40139, Bologna
Azienda Sanitaria Locale Br
Neurology, Via Napoli 8, 72100, Brindisi
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Dipartimento di Medicina, Chirurgia e Odontoiatria, Largo Citta' D'ippocrate 1, 84131, Salerno
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Clinica Neurologica e Neurofisiopatologia, Via Santa Maria Di Costantinopoli 104, 80138, Naples
Irccs San Raffaele Roma S.r.l.
Clinical Trial Center, Via Di Val Cannuta 250, 00166, Rome
St Antonius Hospital
Neurology, Soestwetering 1, 3543 AZ, Utrecht
Amsterdam UMC
Neurology, De Boelelaan 1117, 1081 HV, Amsterdam
Centrum Medyczne Neuromed Sp. z o.o.
N/A, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Krakowska Akademia Neurologii Sp. z o.o.
N/A, Ul. Arianska 7/3, 31-505, Cracow
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
N/A, Ul. Andrzeja Struga 49/51, 90-640, Lodz
Centro Hospitalar Universitario Sao Joao E.P.E.
Neurology, Alameda Professor Hernani Monteiro, 4200-319, Porto
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
Neurology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Centro Hospitalar E Universitario De Coimbra E.P.E.
Neurology, Praceta Professor Mota Pinto, 3000-459, Coimbra
CNS Saude Lda.
Neurology, Bairro De Santo Antonio 47, 2560-280, Torres Vedras
Unidade Local De Saude De Santo Antonio E.P.E.
Neurology, Largo Professor Abel Salazar, 4050-011, Porto
Hospital De La Santa Creu I Sant Pau
Neurology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
University Hospital Virgen Del Rocio S.L.
Neuroscience, Movements disorders Unit, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Cruces
Neurology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitari Germans Trias I Pujol
Neurology, Carretera Canyet 1a Planta, 08916, Badalona
Vall D'hebron Institut De Recerca
Neurology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario De La Princesa
Neurology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Ruber Internacional
Neurology, Calle La Maso 38, 28035, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-10-02 | 2026-03-27 | 2023-10-03 | 2024-08-21 | |
| Germany | 2023-11-23 | 2026-04-01 | 2023-12-19 | 2024-08-29 | |
| Italy | 2023-10-25 | 2026-04-02 | 2023-11-02 | 2024-09-10 | |
| Netherlands | 2024-04-25 | 2025-01-23 | 2024-06-20 | 2024-08-21 | |
| Poland | 2023-11-20 | 2026-03-27 | 2023-11-28 | 2024-08-30 | |
| Portugal | 2023-09-15 | 2025-12-17 | 2023-09-19 | 2024-08-23 | |
| Spain | 2023-07-21 | 2026-04-02 | 2023-07-26 | 2024-09-04 | |
| Sweden | 2023-12-15 | 2026-01-22 | 2024-01-16 | 2024-06-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 148 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-501783-18-00_tracked changes_redacted | 3.0 |
| Protocol (for publication) | D1_Protocol_2022-501783-18-00-redacted | 4.1 |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_CSSRS-Baseline_USA_English | 1 |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_CSSRS-SLV_USA_English | 1 |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_PD-CRS_Clock_English | 1 |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_PD-CRS_English | 1 |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_PD-CRS_StimulusBook_English | N/A |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_PDQ-39_USA_English-redacted | 1 |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_PGI-C_GBR_English | 1 |
| Protocol (for publication) | D4_Patient facing questionnaire_BIA_28-6156-201_PGI-S_English | 1 |
| Protocol (for publication) | D4_Patient facing questionnaire_EQ-5D-5L Paper Self-Complete-US_English | 1 |
| Protocol (for publication) | D4_Site staff facing questionnaire_BIA_28-6156-201_CGI-C_English | 1 |
| Protocol (for publication) | D4_Site staff facing questionnaire_BIA_28-6156-201_CGI-S_English | 1 |
| Protocol (for publication) | D4_Site staff facing questionnaire_BIA_28-6156-201_MDS-UPDRS_English-redacted | 1 |
| Protocol (for publication) | D4_Site staff facing questionnaire_BIA_28-6156-201_mHY_English | 1 |
| Recruitment arrangements (for publication) | K1_patientrecruitment procedure_Portugal | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_redaction_placeholder | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements | 1.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment_material_Care_Partner_Body_text | 0.2 |
| Recruitment arrangements (for publication) | K2_ Recruitment_material_MRI_information | 0.2 |
| Recruitment arrangements (for publication) | K2_ Recruitment_material_Patient_Brochure_PartA | 0.2 |
| Recruitment arrangements (for publication) | K2_ Recruitment_material_Patient_Brochure_PartB_redacted | 0.2 |
| Recruitment arrangements (for publication) | K2_ Recruitment_material_Patient_Flyer_redacted | 2 |
| Recruitment arrangements (for publication) | K2_PartA_Recruitment material_Patient Brochure | 0.2 |
| Recruitment arrangements (for publication) | K2_PartB_Recruitment material_Patient Brochure_redacted | 0.2 |
| Recruitment arrangements (for publication) | K2_Portugal_Care Partners Body text_PT | 0.2 |
| Recruitment arrangements (for publication) | K2_Portugal_MRI information_PT | 0.2 |
| Recruitment arrangements (for publication) | K2_Portugal_Patient Brochure_Part A_PT | 0.2 |
| Recruitment arrangements (for publication) | K2_Portugal_Patient Brochure_PartB_PT_Redacted | 0.2 |
| Recruitment arrangements (for publication) | K2_Portugal_Patient Flyer_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Care Partner Guide | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Care Partners Body Text | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_MRI information | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_MRI information | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_Part A | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_PartB_redacted | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_es_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material-Care Partners Body text_es | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material-MRI information_es | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material-Patient Brochure_Part A_es | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material-Patient Brochure_Part B_es _redacted | 0.2 |
| Subject information and informed consent form (for publication) | L1 BIA 28-6156-201_ita_ICF Pregnancy Follow-Up_clean_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 BIA 28-6156-201_ita_ICF Pregnant Partner Follow-Up_clean_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ ICF Main Subject Part A_Portuguese_redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_ ICF Pregnancy Follow-up_Portuguese | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF-Spain ICF Main Subject Part A_ES_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF-Spain ICF Main Subject Part B_ES_redacted | 6.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF-Spain ICF Pregnancy Follow-Up_ES | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF-Spain_ICF Pregnant Partner Follow-Up_ES | 1.1 |
| Subject information and informed consent form (for publication) | L1__PRT_ICF for optional retrotesting_pt_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main Subject Part B_redacted | 6.2 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner Follow-Up_Portuguese | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Subject Part A_Redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Subject Part B_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional retro-testing_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Subject Part A_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Subject Part B_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-Up | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Follow-Up | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-Spain ICF Optional retroteting_ES_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and Optional retro-testing_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Main_ICF_PartA_redacted | 5.3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Main_ICF_PartB_redacted | 6.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_optional_retrotesting_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Pregnancy_Follow-Up_ICF | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Pregnant_Partner_Follow-Up_ICF | 1.2 |
| Subject information and informed consent form (for publication) | L2_ Site facing questionnaire_C-SSRS-SinceLastVisit | NA |
| Subject information and informed consent form (for publication) | L2_ Site_facing_documents_C-SSRS-Baseline-Screening_AU5-1_es | N/A |
| Subject information and informed consent form (for publication) | L2_ Site_facing_documents_C-SSRS-SinceLastVisit_AU5-1_es | N/A |
| Subject information and informed consent form (for publication) | L2_GP_Letter_clean | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Newsletter_Public | N/A |
| Subject information and informed consent form (for publication) | L2_Other_subject_information_material_Scheduled_Flow_Chart_Study_Assessment_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_EQ-5D-5L | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_EQ-5D-5L_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_MoCA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_MoCA_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PD-CRS_Clock | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PD-CRS_Clock_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PD-CRS_StimulusBook | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PD-CRS_StimulusBook_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PDQ-39 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PDQ-39_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PGI-C | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PGI-C_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PGI-S | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing questionnaire_PGI-S_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents EQ-5D-5L_ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents_MoCA_ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents_PD-CRS | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents_PD-CRS_Clock | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents_PD-CRS_StimulusBook | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents_PDQ-39 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents_PGI-C | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facient_documents_PGI-S | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_EQ-5D-5L | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_EQ-5D-5L | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_MoCA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_MoCA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PD-CRS | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PD-CRS_Clock | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PD-CRS_StimulusBook | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PD-CRS_StimulusBook | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PDQ-39 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PDQ-39 | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PGI-C | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PGI-C | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PGI-S | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_facing_documents_PGI-S | 1 |
| Subject information and informed consent form (for publication) | L2_PRT_Patient newsletter_PT_Public | N/A |
| Subject information and informed consent form (for publication) | L2_Site facing questionnaire_C-SSRS-Baseline-Screening | NA |
| Subject information and informed consent form (for publication) | L2_Site facing questionnaire_MDS-UPDRS | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site facing questionnaire_PD-CRS | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site staff facing questionnaire_MDS-UPDRS_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site staff facing questionnaire_PD-CRS_es | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_C-SSRS-Baseline-Screening | n/a |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_C-SSRS-Baseline-Screening | 5.1 |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_C-SSRS-Baseline-Screening | N/A |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_C-SSRS-SinceLastVisit | n/a |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_C-SSRS-SinceLastVisit | N/A |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_C-SSRS-SinceLastVisit_ | 5.1 |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_MDS-UPDRS | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_MDS-UPDRS | 1 |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_MDS-UPDRS_ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_PD-CRS | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site_facing_documents_PD-CRS | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis ESP Spanish 2022-501783-18-00_TC_redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis ESP Spanish 2022-501783-18-00 redacted | 4.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary DEU 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary DEU 2022-501783-18-00_redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary ENG 2022-501783-18-00 redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary ESP 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary ESP 2022-501783-18-00_redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary FRA 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary FRA 2022-501783-18-00_redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary ITA 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary ITA 2022-501783-18-00_redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary NLD 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary NLD 2022-501783-18-00_redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary POL 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary POL 2022-501783-18-00_redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary PRT 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary PRT 2022-501783-18-00_redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary SWE 2022-501783-18-00 TC redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Summary SWE 2022-501783-18-00_redacted | 3.1 |
Application history
22 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-12 | Germany | Acceptable 2023-04-14
|
2023-06-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-01 | Germany | Acceptable 2023-04-14
|
2023-09-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-13 | Germany | Acceptable 2024-03-12
|
2024-03-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-28 | Acceptable 2024-03-12
|
2024-03-28 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-04-11 | Germany | Acceptable 2024-03-12
|
2024-04-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-29 | Germany | Acceptable | 2024-05-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-05-02 | Acceptable | 2024-05-30 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-05-08 | Acceptable | 2024-07-05 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-05-10 | Acceptable | 2024-07-15 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-05-17 | Acceptable | 2024-06-19 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-05-21 | Acceptable | 2024-06-27 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-05-21 | Acceptable | 2024-06-28 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-06-04 | Acceptable | 2024-07-15 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-06-21 | Acceptable | 2024-07-11 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-07-16 | Germany | 2024-07-16 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-09-26 | Germany | 2024-09-26 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-02-26 | Germany | Acceptable 2025-06-02
|
2025-06-03 |
| 18 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-06-10 | Acceptable | 2025-08-05 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-06-12 | Acceptable | 2025-07-01 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-06-13 | Acceptable | 2025-07-14 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-07-22 | Acceptable | 2025-08-01 | |
| 22 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-09-11 | Germany | Acceptable | 2025-09-11 |