Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
7
Countries
1
Sites
1
Multiple sclerosis
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 17 Feb 2025 → ongoing
- Decision date (initial)
- 2024-10-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515563-55-00
- EudraCT number
- 2016-000720-26
- ClinicalTrials.gov
- NCT02912897
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple sclerosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- David LAPLAUD
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- David LAPLAUD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 7 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Neurology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
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 | 2021-01-26 | 2021-01-26 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-67764
- Halt date
- 2025-01-24
- Planned restart
- 2025-04-07
- Member states concerned
- France
- Publication date
- 2025-01-24
- Reason
- Study management related, Sponsor decision
- Explanation
- Pending authorization to extend the recruitment period
- Follow-up measures
- There are no ongoing subjects on the trial
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | France | Acceptable 2024-10-03
|
2024-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | France | Acceptable 2025-02-03
|
2025-02-12 |