Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
60
Countries
1
Sites
1
idiopathic hypersomnia
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Montpellier
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-07-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
idiopathic hypersomnia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10075058 | Idiopathic hypersomnia | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Montpellier
- Sponsor organisation
- Centre Hospitalier Universitaire De Montpellier
- Address
- 191 Avenue Du Doyen Gaston Giraud
- City
- Montpellier Cedex 5
- Postcode
- 34295
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Montpellier
- Contact name
- Amelle ISSA
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Montpellier
- Contact name
- Amelle ISSA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
Neurologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-05 | France | Acceptable 2024-07-10
|
2024-07-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-06 | France | Acceptable 2025-07-15
|
2025-08-07 |