Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Temporarily halted
Participants planned
80
Countries
1
Sites
3
Multiple sclerosis
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 27 Aug 2024 → ongoing
- Decision date (initial)
- 2024-03-18
- 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
Multiple sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029205 | Nervous system disorders | 8 |
| 20.1 | LLT | 10039720 | Sclerosis multiple | 10029205 |
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Bruno STANKOFF
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Sophie Courtial-Destembert
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 80 | 3 |
| 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 | 2024-08-27 | 2024-08-27 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-113403
- Halt date
- 2024-10-29
- Planned restart
- 2026-05-31
- Member states concerned
- France
- Publication date
- 2026-01-05
- Reason
- Sponsor decision
- Explanation
- Due to difficulties encountered in sourcing experimental products, the sponsor decided to suspend enrolment in the study pending the establishment of a permanent supply chain with a partner for the supply of experimental products.
No patients initiated experimental treatment prior to the suspension of enrolment. - Follow-up measures
- Contract negotiation with a potential industrial partner to supply experimental products
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | France | Acceptable 2024-03-11
|
2024-03-18 |