Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
150
Countries
3
Sites
10
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)
- 2026-06-21
- 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
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 4 | 1 |
| Netherlands | Ongoing, recruiting | 140 | 5 |
| Sweden | Authorised, recruitment pending | 6 | 4 |
| 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
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department of Neurology, Bla Straket 5, Goteborgs Annedal, Goteborg
Region Skane Skanes Universitetssjukhus
Swedish Parkinson Academy, Neurology, Entregatan 7, 222 42, Lund
Karolinska University Hospital
Medical Unit of Neurology, Halsovagen, Flemingsberg, Huddinge
CTC Clinical Trial Consultants AB
VO Neuro / IMV, Ingang 85 Vaning 2, 751 85, Uppsala
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
8 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 |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2026-04-01 | 2026-06-21 | ||
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2026-04-02 | 2026-06-10 |