Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Parkinson's disease
Key facts
- Sponsor
- Bial R&D Investments S.A.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 25 Aug 2025 → ongoing
- Decision date (initial)
- 2025-08-22
- 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'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
Bial R&D Investments S.A.
- Sponsor organisation
- Bial R&D Investments S.A.
- Address
- Avenida Da Siderurgia Nacional, Sao Mamede Do Coronado Sao Mamede Do Coronado
- City
- Trofa
- Postcode
- 4745-457
- Country
- Portugal
Scientific contact point
- Organisation
- Bial R&D Investments S.A.
- Contact name
- -
Public contact point
- Organisation
- Bial R&D Investments S.A.
- Contact name
- -
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 40 | 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 |
|---|---|---|---|---|---|
| Hungary | 2025-08-25 | 2025-08-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-22 | Hungary | Acceptable 2025-08-12
|
2025-08-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-30 | Hungary | Acceptable 2025-08-12
|
2025-09-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-04 | Hungary | Acceptable 2025-11-28
|
2025-12-10 |