Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
586
Countries
8
Sites
42
Mild to moderate Alzheimer’s Disease
To see if people with mild to moderate AD taking KarXT+KarX-EC improve in their thinking skills and global functioning (cognitive impairment and global functioning impairment).
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 18 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-520746-30-00
- WHO UTN
- U1111-1317-4462
- ClinicalTrials.gov
- NCT06976216
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To see if people with mild to moderate AD taking KarXT+KarX-EC improve in their thinking skills and global functioning (cognitive impairment and global functioning impairment).
Secondary objectives 3
- To see if people with mild to moderate AD taking KarXT+KarX-EC improve in their ability to perform daily tasks (functional impairment).
- To see if people with mild to moderate AD with behavioral symptoms (problems with mood or behavior) taking KarXT+KarX-EC improve in these symptoms.
- To evaluate the safety and tolerability of KarXT + KarX-EC in participants with mild to moderate AD.
Conditions and MedDRA coding
Mild to moderate Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
| 20.0 | PT | 10012271 | Dementia Alzheimer's type | 100000004852 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Males and females aged between 60 and 85 years.
- Participants must have an MMSE score ranging from 12 through 22, inclusive, at the time of screening.
- Participants are required to have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication and study procedure compliance, and assisting with medication administration.
- Participants on AChEIs and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.
Exclusion criteria 4
- Participants with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment.
- Participants with primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and to those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
- Participants with a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
- Participants with significant pathological findings on brain MRI at screening that could affect safety or interfere with study procedures.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Change from baseline in ADAS-Cog11 at Week 24
- CIBIC+ at Week 24
Secondary endpoints 4
- Change from baseline in ADCS-ADL at Week 24
- Change from baseline in NPI total score at Week 24
- Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24
- Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD12404386 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12404377 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12404394 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12404368 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408417 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408431 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408423 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408422 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
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
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
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT Representative
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT Representative
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Other |
| Clario ORL-000001148
|
Philadelphia, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Other |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10, Other |
Locations
8 EU/EEA countries · 42 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Authorised, recruiting | 24 | 5 |
| Czechia | Ongoing, recruiting | 45 | 7 |
| Germany | Ongoing, recruiting | 30 | 6 |
| Greece | Ongoing, recruiting | 32 | 5 |
| Italy | Authorised, recruiting | 15 | 4 |
| Poland | Ongoing, recruiting | 20 | 4 |
| Romania | Ongoing, recruiting | 25 | 5 |
| Spain | Ongoing, recruiting | 34 | 6 |
| Rest of world
Korea, Republic of, Brazil, India, Australia, Canada, Argentina, United States, Chile
|
— | 361 | — |
Investigational sites
Klinicki Bolnicki Centar Osijek
Klinika za neurologiju, Ulica Josipa Huttlera 4, 31000, Osijek
Poliklinika Neuron
Psihijatrija, Salata 12, 10000, Grad Zagreb
Klinika za psihijatriju Vrapce
Zavod za biologijsku psihijatriju i psihogerijatriju, Bolnicka Cesta 32, Zagreb, Grad Zagreb
KBC Zagreb
Klinika za neurologiju, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Clinical Hospital Centre Rijeka
Klinika za neurologiju, Kresimirova 42, 51000, Rijeka
Neuropsychiatrie s.r.o.
NA, Terronska 580/19, Bubenec, Prague 6
AGE Centrum s.r.o.
NA, Na Sibeniku 914/1 Nova Ulice, 779 00, Olomouc
Neuro Health Centrum s.r.o.
NA, Hornikova 2485/34, Lisen, Brno-Lisen
Forbeli s.r.o.
NA, Kolejni 429/5 Dejvice, 160 00, Prague
INEP medical s.r.o.
NA, Krizikova 264/22, Karlin, Prague
Vestra Clinics s.r.o.
NA, Jiraskova 1389, 516 01, Rychnov Nad Kneznou
A-Shine s.r.o.
NA, Sumavska 2, Vychodni Predmesti, Plzen 3
Charite Universitaetsmedizin Berlin KöR
Klinik für Psychiatrie und Psychotherapie, Hindenburgdamm 30, Lichterfelde, Berlin
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Neurologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaet Muenster
Klinik für Neurologie mit Institut für Translationale Neurologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Gesundheit Nord gGmbH Klinikverbund Bremen
Klinik für Neurologie, Zuericher Strasse 40, Ellenerbrok-Schevemoor, Bremen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinik für Psychatrie und Psychotherapie, Untere Zahlbacher Strasse 8, Oberstadt, Mainz
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Zentrum für kognitive Störungen, Ismaninger Strasse 22, Au-Haidhausen, Munich
401 General Military Hospital Of Athens
Department of Neurology, Panagioti Kanellopoulou Av 1, 115 25, Athens
General University Hospital Of Larissa
Department of Neurology, P. O. Box 1425, 411 10, Larissa
University General Hospital Of Thessaloniki Ahepa
B’ Department of Neurology, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Of Alexandroupoli
Department of Neurology, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Eginitio Hospital
A’ Department of Neurology, Vassilissas Sofias Avenue 74, 115 28, Athens
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Neurology, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliera S Gerardo Di Monza Laboratorio Per La Terapia Cellulare E Genica Stefano Verri
Neurology, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurology, Piazzale Spedali Civili 1, 25123, Brescia
Ospedale San Raffaele S.r.l.
Neurology, Via Olgettina 60, 20132, Milan
Centrum Badan Klinicznych Pi-House Sp. z o.o.
-, Ul. Na Zaspe 3, 80-546, Gdansk
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski
-, ul. Młynowa 38 lok. 13U, 15-404, Bialystok
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska
-, ul. Konstantego Ildefonsa Galczynskiego 45, 87-100, Torun
Centrum Medyczne Hcp Sp. z o.o.
-, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Strada Argeselu Nr 8, 040874, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Institutul De Psihiatrie Socola Iasi
Psychiatry, Soseaua Bucium 36, 700282, Jassi
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
Psychiatry, Strada Căldărușani, Nr. 9, Bucharest
Hospital Universitari General De Catalunya
Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Universitari De Santa Maria
Cognitive Impairment Unit, Av Alcalde Rovira Roure 44, 25198, Lleida
Hospital Clinic De Barcelona
Alzheimer's disease and other cognitive disorders unit, Calle Villarroel 170, 08036, Barcelona
Clinica Universidad De Navarra
Neurology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Victoria Eugenia De La Cruz Roja Espanola
UNIDAD DE NEUROCIENCIAS, Avenida La Cruz Roja 1, 41009, Sevilla
Hospital Clinico San Carlos
Neurology, Calle Del Profesor Martin Lagos Sn, 28040, 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 |
|---|---|---|---|---|---|
| Croatia | 2026-03-05 | ||||
| Czechia | 2025-11-18 | 2026-01-14 | |||
| Germany | 2025-12-11 | 2026-01-21 | |||
| Greece | 2026-01-12 | 2026-01-29 | |||
| Italy | 2025-12-11 | ||||
| Poland | 2026-02-03 | 2026-03-03 | |||
| Romania | 2025-12-01 | 2025-12-02 | |||
| Spain | 2025-11-26 | 2025-11-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 96 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol GR 2025-520746-30-00_Redacted | 02 EU |
| Protocol (for publication) | D1_Protocol 2025-520746-30-00_redacted | 02 EU |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | 1 |
| Protocol (for publication) | D4_Patient facing documents_COA not for publication statement_CZ_CS_public | NA |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_ES | NA |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_HR | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_ENG | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_GER_DE | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_GR | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_IT | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1.0 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_HR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 2 |
| Recruitment arrangements (for publication) | K2 Recruitment Material Caregiver Fact Sheet | 1 |
| Recruitment arrangements (for publication) | K2 Recruitment Material Recruitment Poster | 1 |
| Recruitment arrangements (for publication) | K2 Recruitment Material - Caregiver Fact Sheet_GR | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment Material - Recruitment Poster_GR | 1.0 |
| Recruitment arrangements (for publication) | K2 Statement Recruitment Material_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material - Caregiver Fact Sheet_ES | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Recruitment_Poster_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Caregiver Fact Sheet_DE_GER | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Caregiver Fact Sheet_HR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Caregiver_Fact_Sheet_ RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_DE_GER | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_HR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Statement_HR | 1 |
| Recruitment arrangements (for publication) | K2_Statement of the recruitment material_GER_DE | NA |
| Recruitment arrangements (for publication) | K2_Statement on validated Recruitment Material _GR | NA |
| Recruitment arrangements (for publication) | K2_Statement on validated recruitment materials under licence_RO | 1 |
| Recruitment arrangements (for publication) | K2_Statement_Recruitment material-Study Intro Trifold_ES | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Greenphire_HR_Unedacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_HR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research_HR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Open Label Extension_HR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Participant_HR_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Study Partner_HR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Open Label Extension | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Open Label Extension_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Study Partner | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Study Partner_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Assent_clean_re-redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Future Research_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_OLE_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Study Partner_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_final_POL_Re-redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_final_POL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE IC _final_POL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Open Label Extension_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_final_POL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Open Label Extension Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Open-label Extension_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant _final_POL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy notice_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner _GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_final_POL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Travel reimbursement_FINAL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_CZ_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_CZ_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF Optional Future Research_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IOCBP_CZ_public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PDP_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | NL1_SIS and ICF Assent_Redatto | 1.0 |
| Subject information and informed consent form (for publication) | NL1_SIS and ICF Study Partner Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis GR 2025-520746-30-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PL 2025-520746-30-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_CS 2025-520746-30-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG 2025-520746-30-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HR 2025-520746-30-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT 2025-520746-30-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO 2025-520746-30-00 | 4 |
| Synopsis of the protocol (for publication) | D1-Protocol synopsis_ES 2025-520746-30-00 | 4 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Germany | Acceptable 2025-10-20
|
2025-10-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-05 | Germany | Acceptable 2025-10-20
|
2025-11-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-19 | Germany | Acceptable 2026-01-29
|
2026-01-29 |