Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
75
Countries
1
Sites
1
Narcolepsy with cataplexy
Key facts
- Sponsor
- Bioprojet Pharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 13 Jun 2023 → 24 Jul 2024
- Decision date (initial)
- 2023-06-13
- 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 | PT | 10028713 | Narcolepsy | 100000004852 |
| 20.0 | LLT | 10028715 | Narcolepsy with cataplexy | 10029205 |
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 | 75 | 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 | 2023-06-13 | 2024-07-24 | 2023-07-03 | 2024-07-24 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-24 | Belgium | Acceptable 2023-06-07
|
2023-06-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-15 | Belgium | Acceptable | 2023-07-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-18 | Belgium | Acceptable 2024-07-09
|
2024-07-26 |