Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruiting
Participants planned
2
Countries
1
Sites
1
Parkinson disease
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Lille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 1 Oct 2025 → ongoing
- Decision date (initial)
- 2025-08-20
- 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
Parkinson 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
Centre Hospitalier Universitaire De Lille
- Sponsor organisation
- Centre Hospitalier Universitaire De Lille
- Address
- 2 Avenue Oscar Lambret, Cs 70001 Cs 70001
- City
- Lille Cedex
- Postcode
- 59037
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- David DEVOS
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- David DEVOS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 2 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Neurology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
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 | 2025-10-01 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-20 | France | Acceptable 2025-08-14
|
2025-08-20 |