Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
15
Countries
1
Sites
2
Primary Progressive Multiple Sclerosis
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Rennes
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 6 Mar 2025 → ongoing
- Decision date (initial)
- 2024-07-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Primary Progressive Multiple Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063401 | Primary progressive multiple sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Rennes
- Sponsor organisation
- Centre Hospitalier Universitaire De Rennes
- Address
- 2 Rue Henri Le Guilloux
- City
- Rennes
- Postcode
- 35000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Rennes
- Contact name
- Laure MICHEL
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Rennes
- Contact name
- Laure MICHEL
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 15 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2025-03-06 | 2025-03-06 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-29 | France | Acceptable 2024-07-03
|
2024-07-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-21 | France | Acceptable | 2024-12-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-05 | France | Acceptable 2025-08-07
|
2025-08-07 |