Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
140
Countries
1
Sites
5
Parkinson’s Disease
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- 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
- 9 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
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
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 140 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Brain Research Center Zwolle B.V.
N/A, Dokter Stolteweg 90, 8025 AZ, Zwolle
Brain Research Center Den Bosch B.V.
N/A, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Brain Research Center Amsterdam B.V.
N/A, Cronenburg 2, 1081 GN, Amsterdam
Radboud universitair medisch centrum Stichting
N/A, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
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 | 2024-09-09 | 2024-09-10 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-03 | Netherlands | Acceptable 2024-08-27
|
2024-08-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-18 | Netherlands | Acceptable 2024-08-27
|
2024-10-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-27 | Netherlands | Acceptable 2025-09-15
|
2025-09-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-03 | Netherlands | Acceptable 2025-09-15
|
2025-12-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-14 | Netherlands | Acceptable 2025-09-15
|
2026-01-14 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-26 | Netherlands | Acceptable 2025-09-15
|
2026-03-26 |