Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
12
Countries
1
Sites
1
Parkinson's disease
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Lille, InBrain Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- completed 2 Oct 2025
- Decision date (initial)
- 2024-11-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517566-42-00
- EudraCT number
- 2020-000155-12
- ClinicalTrials.gov
- NCT04332276
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
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
- Brigitte COURTOIS
InBrain Pharma
- Sponsor organisation
- InBrain Pharma
- Address
- Parc Eurasante Ouest, 70 Rue Du Docteur Yersin 70 Rue Du Docteur Yersin
- City
- Loos
- Postcode
- 59120
- Country
- France
Scientific contact point
- Organisation
- InBrain Pharma
- Contact name
- Véronique FOUTEL
Public contact point
- Organisation
- InBrain Pharma
- Contact name
- Véronique FOUTEL
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Neurology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | France | Acceptable 2024-11-14
|
2024-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-02 | France | Acceptable 2025-05-16
|
2025-05-16 |