Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
89
Countries
1
Sites
15
Progressive multiple sclerosis
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 19 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516433-13-00
- EudraCT number
- 2021-006107-15
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Progressive multiple sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10052785 | Multiple sclerosis acute and progressive | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Pr LEBRUN-FRENAY
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Mélanie Bonnard
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 89 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional De Marseille
Neurology, 144 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Caen Normandie
Neurology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
CHU Amiens - Groupe Hospitalier Sud
Neurology, 1 1 rond-point du Professeur Cabrol, 80054, AMIENS
Les Hopitaux Universitaires De Strasbourg
Neuropogy, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier De La Cote Basque
neurology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Universitaire De Nimes
Neurology, Place Du Professeur Robert Debre, 30900, Nimes
Centre Hospitalier Universitaire De Montpellier
Neurology, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
CHU de Nantes - Hôpital Laennec
Neurology, Boulevard Jacques Monod, 44093, Nantes Cedex 1
CHRU De Nancy
neurology, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Centre Hospitalier Universitaire De Lille
Neurology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centre Hospitalier Universitaire De Bordeaux
Neurology, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Rennes
Neurology, 2 Rue Henri Le Guilloux, 35000, Rennes
CHU Gabriel-Montpied
Neurology, 58 Rue Montalembert, 63000, Clermont Ferrand
Hospices Civils De Lyon
Neurology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Nice
Neurology, 30 Voie Romaine, 06000, Nice
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 | 2024-09-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | France | Acceptable 2024-09-16
|
2024-09-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-28 | France | Acceptable 2025-09-30
|
2025-10-02 |