Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
16
Countries
1
Sites
1
narcolepsy with cataplexy
Key facts
- Sponsor
- Bioprojet Pharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Apr 2025 → 18 Oct 2025
- Decision date (initial)
- 2025-03-06
- 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
narcolepsy with cataplexy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10028715 | Narcolepsy with cataplexy | 10029205 |
| 20.0 | PT | 10028713 | Narcolepsy | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bioprojet Pharma
- Sponsor organisation
- Bioprojet Pharma
- Address
- 9 Rue Rameau
- City
- Paris
- Postcode
- 75002
- Country
- France
Scientific contact point
- Organisation
- Bioprojet Pharma
- Contact name
- Clinical development director
Public contact point
- Organisation
- Bioprojet Pharma
- Contact name
- Clinical development director
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Belgium | 2025-04-08 | 2025-10-18 | 2025-04-08 | 2025-05-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-11 | Belgium | Acceptable 2025-03-06
|
2025-03-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-03 | Belgium | Acceptable 2025-03-06
|
2025-06-03 |