Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
586
Countries
10
Sites
56
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
- 29 Oct 2025 → ongoing
- Decision date (initial)
- 2025-10-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-520747-32-00
- WHO UTN
- U1111-1317-4515
- ClinicalTrials.gov
- NCT06976203
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 | PT | 10012271 | Dementia Alzheimer's type | 100000004852 |
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
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 assissting 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
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
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
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 |
|---|---|---|
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10, Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Other |
| Clario ORL-000001148
|
Philadelphia, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
Locations
10 EU/EEA countries · 56 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 30 | 5 |
| France | Ongoing, recruiting | 50 | 12 |
| Germany | Ongoing, recruiting | 30 | 6 |
| Greece | Ongoing, recruiting | 32 | 5 |
| Italy | Authorised, recruiting | 12 | 3 |
| Netherlands | Ongoing, recruiting | 25 | 3 |
| Poland | Ongoing, recruiting | 20 | 4 |
| Portugal | Ongoing, recruiting | 32 | 6 |
| Romania | Ongoing, recruiting | 25 | 5 |
| Spain | Ongoing, recruiting | 36 | 7 |
| Rest of world
Brazil, United States, Japan, Australia, Argentina, United Kingdom
|
— | 294 | — |
Investigational sites
Suomen Terveystalo Oy
Terveystalo Oulu, Albertinkatu 16, 90100, Oulu
University Of Eastern Finland
Brain Reserach Unit, Faculty of Medicine, P. O. Box 1627, 70211, Kuopio
Clinical Research Services Turku CRST Oy
CRST Turku Oy, Joukahaisenkatu 2 B, 20520, Turku
Suomen Terveystalo Oy
Terveystalo Helsinki, Porkkalankatu 22 A, 00180, Helsinki
CRST Helsinki Oy
CRST Helsinki Oy, Energiakatu 4, 00180, Helsinki
Centre Hospitalier Universitaire De Lille
Hôpital Roger Salengro, Neurologie, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Hôpital Lariboisière - Centre de Neurologie Cognitive, 2 Rue Ambroise Pare, 75010, Paris
Centre Hospitalier Universitaire De Rennes
Centre Mémoire de Ressource de Recherche (CMRR), 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Hospitalier Universitaire De Toulouse
Gérontopôle, Place Lange, 31059, Toulouse Cedex 9
Centre Hospitalier Regional De Marseille
Hôpital de la Timone - Service de Neurologie et de Neuropsychologie, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Bordeaux
Neurologie, Place Amelie Raba Leon, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Hôpital Broca, Département gériatrique, 54 56 Rue Pascal 54a, 75013, Paris
CHRU De Nancy
Hôpital centre Neurologie, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Les Hopitaux Nord-Ouest
Gérontologie, Plateau D Ouilly, Cs 80436 Gleize, Villefranche Sur Saone Cedex
Les Hopitaux Universitaires De Strasbourg
Hôpital de la Robertsau - Centre Mémoire de Ressources et de Recherche, 21 Rue David Richard, 67000, Strasbourg
Hospices Civils De Lyon
Hôpital neurologique Pierre Wertheimer, Service de Neuropsychologie, Unité 502, 59 Boulevard Pinel, 69500, Bron
Hopitaux Universitaires Pitie Salpetriere
Neurologie, 47 To 83 Boulevard De L Hopital, 75013, Paris
University Hospital Cologne AöR
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsmedizin Goettingen
Klinik für Psychiatrie und Psychotherapie, Von-Siebold-Strasse 5, 37075, Goettingen
Pharmakologisches Studienzentrum Chemnitz GmbH
Pharmakologisches Studienzentrum Chemnitz, Carolastrasse 2, Zentrum, Chemnitz
Universitaetsklinikum Ulm AöR
Gedächtnissprechstunde und Studienteam Demenz, Oberer Eselsberg 45, Eselsberg, Ulm
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Dr. I. Schöll GmbH, Hessenring 121, 61348, Bad Homburg
LMU Klinikum Muenchen AöR
Klinik fuer Psychiatrie und Psychotherapie, Nussbaumstrasse 7, Ludwigsvorstadt-Isarvorstadt, Munich
University General Hospital Of Thessaloniki Ahepa
1st Department of Neurology, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Attikon
2nd Department of Neurology, Rimini Street 1, 124 62, Athens
General University Hospital Of Patras
Department of Neurology, Rio, 265 04, Patras
University General Hospital Of Ioannina
Neurology Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
Neurodegenerative Brain Diseases Department – Memory Clinic, Erithrou Stavrou 4, 151 24, Maroussi
Azienda Ospedaliera Universitaria Federico II Di Napoli
Neurology, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Ospedali Riuniti
Neurology, Viale Luigi Pinto 1, 71122, Foggia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neurology, Largo Francesco Vito 1, 00168, Rome
Brain Research Center Amsterdam B.V.
Alzheimer centra, Cronenburg 2, 1081 GN, Amsterdam
Brain Research Center Den Bosch B.V.
Alzheimer centra, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Brain Research Center Zwolle B.V.
Alzheimer centra, Dokter Stolteweg 90, 8025 AZ, Zwolle
Instytut Naukowo-Badawczy w Lublinie Sp. z o.o.
M&D Centrum Medyczne, Ul. Polnocna 20, 20-064, Lublin
EMC Silesia Sp. z o.o.
Poradnia Geriatryczna, Ul. Morawa 31, 40-353, Katowice
Penta Hospitals Przychodnie
Wrocław Wejherowska, ul. Wejherowska 28, bud. 4, Wroclaw
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
n/a, Ul. Gen. Jaroslawa Dabrowskiego 4, 32-600, Oswiecim
CNS Saude Lda.
Neurology, Bairro De Santo Antonio 47, 2560-280, Torres Vedras
Unidade Local De Saude De Matosinhos E.P.E.
Neurology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude De Santo Antonio E.P.E.
Neurology, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude Do Alto Ave E.P.E.
Neurology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude De Coimbra E.P.E.
Neurology, Praceta Professor Mota Pinto, 3004-561, Coimbra
CCAB Centro Clinico Academico Braga Associacao
Neurology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Psychiatry, Strada Vulcanescu Mircea 88, 010825, Bucharest
Brainaxy Clinic S.R.L.
Neurology, Strada Muresanu Andrei No. 8, 900348, Constanta
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psychiatry, Strada Prundului 7-9, 500123, Brasov
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Hospital Ruber Juan Bravo
Neurology, Calle De Juan Bravo 49, 28006, Madrid
Hospital Universitario Marques De Valdecilla
Neurology, Avenida Valdecilla Sn, 39008, Santander
Fundacio Ace Institut Catala De Neurociencies Aplicades
Neurology, Gran Via De Carles III 85 Bis, 08028, Barcelona
Hospital Universitario 12 De Octubre
Neorology, Avenida De Cordoba Sn, 28041, Madrid
Policlinica Gipuzkoa S.A.
Neurology, Paseo Miramon 174, 20009, Donostia
Hospital Universitario Dr Peset Aleixandre
Neurology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitario Quironsalud Madrid
Neurology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 |
|---|---|---|---|---|---|
| Finland | 2025-11-28 | 2025-12-16 | |||
| France | 2025-10-29 | 2025-11-03 | |||
| Germany | 2025-11-04 | 2025-11-18 | |||
| Greece | 2025-12-30 | 2026-01-23 | |||
| Italy | 2025-12-10 | ||||
| Netherlands | 2025-11-17 | 2025-12-04 | |||
| Poland | 2026-02-13 | 2026-02-25 | |||
| Portugal | 2025-12-10 | 2025-12-16 | |||
| Romania | 2025-12-01 | 2026-04-29 | |||
| Spain | 2025-11-25 | 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 129 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol GR 2025-520747-32-00_Redacted | 02 EU |
| Protocol (for publication) | D1_Protocol 2025-520747-32-00_redacted | 02 EU |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | n/a |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_ES | NA |
| Protocol (for publication) | D4_Patient facing documents_Statement_Questionnaires under licence_FR | 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 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_PT | 1 |
| Recruitment arrangements (for publication) | D4_Statement of the recruitment material_GER_DE | NA |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 2.0 |
| Recruitment arrangements (for publication) | K2 Recruitment Material - Caregiver Fact Sheet_GR | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment Material - Recruitment Poster - V1_it | 1 |
| Recruitment arrangements (for publication) | K2 Recruitment Material - Recruitment Poster_GR | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment Material- Caregiver Fact Sheet V1_it | 1 |
| Recruitment arrangements (for publication) | K2 Recruitment Material- HCP Referral Letter and Fact Sheet - V1_it | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material _Caregiver_Fact_Sheet RO | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Appointment_Reminder_Card_RO | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Recruitment_Poster_Europe_RO | 1 |
| Recruitment arrangements (for publication) | K2_ES_Statement_Recruitment material-Study Intro Trifold-EU | N/A |
| Recruitment arrangements (for publication) | K2_NL_Recruitment material Caregiver fact sheet | 1.1 |
| Recruitment arrangements (for publication) | K2_NL_Recruitment material Recruitment poster | 1.2 |
| Recruitment arrangements (for publication) | K2_NL_Recruitment material_Statement_Website text | N/A |
| Recruitment arrangements (for publication) | K2_NL_Recruitment material_Statement_Welcome presentation | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Caregiver Fact Sheet _PT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Caregiver Fact Sheet_DE_GER | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Caregiver Fact Sheet_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Caregiver Fact Sheet_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_DE_GER | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Statement_Study Intro Trifold_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material-Caregiver Fact Sheet_ES | 1 |
| Recruitment arrangements (for publication) | K2_recruitment materials_statement_PL | n/a |
| Recruitment arrangements (for publication) | K2_Statement on 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_IT | 1 |
| Recruitment arrangements (for publication) | K2_Statement_Recruitment Material_Study Intro Trifold_PT | 1 |
| Recruitment arrangements (for publication) | K2_Subject Recruitment material _Ad short 1 | 1 |
| Recruitment arrangements (for publication) | K2_Subject Recruitment material _Ad short_2 | 1 |
| Recruitment arrangements (for publication) | K2_Subject Recruitment material _pictures | 1 |
| Recruitment arrangements (for publication) | K2_Subject Recruitment material_Ad short 3 | 1 |
| Recruitment arrangements (for publication) | K2_Subject Recruitment material_CRST web site | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Open Label Extension | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Open Label Extension_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research | 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 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Study Partner_Redacted | 1 |
| 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_re-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_Pregnant Participant_clean_no redactions | 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_ICF and SIS Assent_PT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF and SIS Main_PT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF and SIS Optional Future Research_PT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF and SIS Optional Open Label Extension_PT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF and SIS Study Partner_PT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Adult Assent IC Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Main IC Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Optional Future Research IC Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Optional Open-Label extension IC Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Pregnant Participant IC Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Study Partner IC Redacted | 1.1 |
| 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_FR_Redacted | 1.1 |
| 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 Assent_PL_Re-redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LAR Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LAR OLE Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 1 |
| 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_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE Assent_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE_PL_Redacted | 1.0 |
| 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_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_FR_Redacted | 1.1 |
| 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 OLE_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_PL_Redacted | 1.0 |
| 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 IC template | 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 | 1.1 |
| 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_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Travel Reimbursement_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_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_Optional Future Research_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Open Label Extension_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner IC Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_FR | 1.0 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis GR 2025-520747-32-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2025-520747-32-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL 2025-520747-32-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG 2025-520747-32-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2025-520747-32-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT 2025-520747-32-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PT_2025-520747-32-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO 2025-520747-32-00 | 4 |
| Synopsis of the protocol (for publication) | D1-Protocol synopsis_ES 2025-520747-32-00 | 4 |
Application history
4 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 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-11 | Acceptable 2025-10-20
|
2025-11-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-19 | Germany | Acceptable 2026-01-21
|
2026-01-21 |