Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
124
Countries
2
Sites
4
Parkinson’s disease
Key facts
- Sponsor
- Prevail Therapeutics Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2025-04-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513411-27-00
- ClinicalTrials.gov
- NCT06565195
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Parkinson’s disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Prevail Therapeutics Inc.
- Sponsor organisation
- Prevail Therapeutics Inc.
- Address
- 645 Summer Street
- City
- Boston
- Postcode
- 02210-2135
- Country
- United States
Scientific contact point
- Organisation
- Prevail Therapeutics Inc.
- Contact name
- Regulatory Department
Public contact point
- Organisation
- Prevail Therapeutics Inc.
- Contact name
- Regulatory Department
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 7 | 2 |
| Netherlands | Authorised, recruitment pending | 3 | 2 |
| Rest of world
United Kingdom, United States, Japan
|
— | 114 | — |
Investigational sites
Universitaetsklinikum Duesseldorf AöR
Zentrum für Bewegungsstörungen und Neuromodulation, Moorenstrasse 5, Bilk, Duesseldorf
Universitaet Muenster
Klinik für Neurologie mit Institut für Translationale Neurologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-27 | Germany | Acceptable 2025-03-31
|
2025-04-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-13 | Germany | Acceptable 2025-03-31
|
2025-11-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-04 | Germany | Acceptable 2026-03-16
|
2026-03-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-16 | Germany | Acceptable 2026-06-01
|
2026-06-02 |