Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
1
Head trauma patient
Key facts
- Sponsor
- Centre Hospitalier Universitaire Grenoble Alpes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 20 Jun 2024 → ongoing
- Decision date (initial)
- 2023-08-23
- 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
Head trauma patient
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Grenoble Alpes
- Sponsor organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Address
- Boulevard De La Chantourne, Cs 10217, La Tronche Cs 10217 La Tronche
- City
- Grenoble Cedex 9
- Postcode
- 38043
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Principal investigator
Public contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Principal investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
Anesthésie/réanimation, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
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 | 2024-06-20 | 2024-07-29 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-02 | France | Acceptable 2023-08-23
|
2023-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-12 | France | Acceptable 2023-10-26
|
2023-10-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-18 | France | Acceptable 2024-05-13
|
2024-05-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-15 | France | Acceptable 2026-03-23
|
2026-03-27 |