Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Dravet syndrome
Key facts
- Sponsor
- Biocodex
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 26 May 2025 → 27 Aug 2025
- Decision date (initial)
- 2025-04-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Dravet syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10073682 | Dravet syndrome | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biocodex
- Sponsor organisation
- Biocodex
- Address
- 22 Rue Des Aqueducs
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Biocodex
- Contact name
- Laurent CHANCHARME
Public contact point
- Organisation
- Biocodex
- Contact name
- Roxane NOEL
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 24 | 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 |
|---|---|---|---|---|---|
| France | 2025-05-26 | 2025-08-27 | 2025-05-26 | 2025-08-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-04 | France | Acceptable 2025-04-10
|
2025-04-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-02 | France | Acceptable 2025-06-11
|
2025-06-11 |