Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
23
Countries
1
Sites
3
Amyotrophic lateral Sclerosis
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2025-03-19
- 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
Amyotrophic lateral Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029205 | Nervous system disorders | 8 |
| 21.1 | PT | 10002026 | Amyotrophic lateral 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
- Coordinating Investigator
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Coordinating Investigator
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 23 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Neurology DepartmentClinical Investigation Center, 43 Boulevard De L Hopital, 75013, Paris
Assistance Publique Hopitaux De Paris
Neurology Department, 43 Boulevard De L Hopital, 75013, Paris
Assistance Publique Hopitaux De Paris
Neurosurgery, 43 Boulevard De L Hopital, 75013, Paris
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-06 | France | Acceptable 2025-03-17
|
2025-03-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-13 | France | Acceptable 2025-06-17
|
2025-07-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-23 | France | Acceptable with conditions 2026-04-07
|
2026-04-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-13 | France | Acceptable with conditions 2026-04-07
|
2026-05-13 |