Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
62
Countries
1
Sites
1
Epilepsy
Key facts
- Sponsor
- Praxis Precision Medicines Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 28 Aug 2024 → 24 Feb 2025
- Decision date (initial)
- 2024-08-21
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065337 | Focal epilepsy | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Praxis Precision Medicines Inc.
- Sponsor organisation
- Praxis Precision Medicines Inc.
- Address
- 99 High Street Floor 30th
- City
- Boston
- Postcode
- 02110-2345
- Country
- United States
Scientific contact point
- Organisation
- Praxis Precision Medicines Inc.
- Contact name
- William Motel
Public contact point
- Organisation
- Praxis Precision Medicines Inc.
- Contact name
- William Motel
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 62 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-08-28 | 2024-08-28 | 2025-01-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | Netherlands | Acceptable 2024-08-21
|
2024-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-13 | Netherlands | Acceptable 2024-12-06
|
2024-12-06 |