Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
8
Countries
1
Sites
1
Epilepsy
Key facts
- Sponsor
- Panntherapi, Eurofins Optimed
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 23 Jul 2024 → 28 Oct 2024
- Decision date (initial)
- 2024-07-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Epilepsy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Panntherapi
- Sponsor organisation
- Panntherapi
- Address
- 10 Rue Descartes
- City
- Nimes
- Postcode
- 30000
- Country
- France
Scientific contact point
- Organisation
- Panntherapi
- Contact name
- Elsa BRILLAUD
Public contact point
- Organisation
- Panntherapi
- Contact name
- Elsa BRILLAUD
Eurofins Optimed
- Sponsor organisation
- Eurofins Optimed
- Address
- 1 Rue Des Essarts
- City
- Gieres
- Postcode
- 38610
- Country
- France
Scientific contact point
- Organisation
- Eurofins Optimed
- Contact name
- Irina VILLE-GUIGARD
Public contact point
- Organisation
- Eurofins Optimed
- Contact name
- Irina VILLE-GUIGARD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 8 | 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 | 2024-07-23 | 2024-10-28 | 2024-07-23 | 2024-09-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-29 | France | Acceptable with conditions 2024-07-01
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-09 | France | Acceptable 2024-09-23
|
2024-09-23 |