Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
88
Countries
1
Sites
4
Patients aged 15 years and 3 months and older with severe head trauma
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] - Nervous System Diseases [C10]
- Trial duration
- 25 Jun 2024 → ongoing
- Decision date (initial)
- 2023-10-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients aged 15 years and 3 months and older with severe head trauma
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
- Vincent DEGOS
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Vincent DEGOS
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 88 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Anesthesia and Critical Care, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
anesthesiology and intensive care medicine, 100 Boulevard Du General Leclerc, 92110, Clichy
Hopital D'Instruction Des Armees Percy
ANESTHESIOLOIST AND INTENSIVE CARE, 101 Avenue Henri Barbusse, 92140, Clamart
Assistance Publique Hopitaux De Paris
Department of Anesthesiology, 43 Boulevard De L Hopital, 75013, Paris
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 | 2024-06-25 | 2024-10-22 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-10 | France | Acceptable 2023-10-13
|
2023-10-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-24 | France | Acceptable 2024-03-20
|
2024-03-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-07 | France | Acceptable 2024-06-07
|
2024-06-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-27 | France | Acceptable 2025-03-31
|
2025-03-31 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-17 | France | Acceptable 2026-02-04
|
2026-02-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-29 | France | Acceptable 2026-02-04
|
2026-05-29 |