Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
144
Countries
1
Sites
6
stroke
Key facts
- Sponsor
- Centre Hospitalier Universitaire Grenoble Alpes
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518394-34-00
- EudraCT number
- 2017-004243-20
- ClinicalTrials.gov
- NCT03570450
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | LLT | 10042244 | Stroke | 10029205 |
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
- Pr Olivier DETANTE
Public contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Pr Olivier DETANTE
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 144 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Neurologie Vasculaire, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Hopitaux Universitaires Pitie Salpetriere
Urgences Cérébro-Vasculaires, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
CHU de Besançon
Neurovasculaire, 3 Bd Fleming, 25030, Besançon Cedex
GHU St Anne Psychiatrie et Neurosciences
Neurovasculaire, 1 rue Cabanis, 75014, Paris
Centre Hospitalier Universitaire Grenoble Alpes
Neurovasculaire, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Neurovasculaire, Place Amelie Raba Leon, 33000, Bordeaux
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | France | Acceptable 2024-10-28
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-15 | France | Acceptable with conditions 2025-02-14
|
2025-02-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-19 | France | Acceptable with conditions | 2025-03-20 |