Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
83
Countries
1
Sites
3
Early Idiopathic Parkinson’s Disease (PD)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- 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 Sep 2022 → 18 Jul 2024
- Decision date (initial)
- 2023-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504412-14-00
- EudraCT number
- 2021-002345-15
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Early Idiopathic Parkinson’s Disease (PD)
| 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 · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 20 | 3 |
| Rest of world
United Kingdom, United States
|
— | 63 | — |
Investigational sites
Brain Research Center Amsterdam B.V.
Brain Research Center Amsterdam, Cronenburg 2, 1081 GN, Amsterdam
Brain Research Center Zwolle B.V.
Brain Research Center Zwolle, Dokter Stolteweg 90, 8025 AZ, Zwolle
Stichting Radboud University Medical Center
Center of Expertise for Parkinson & Movement Disorders, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
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 | 2022-09-01 | 2024-07-18 | 2022-09-14 | 2024-06-06 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-29540
- Halt date
- 2024-06-13
- Member states concerned
- Netherlands
- Publication date
- 2024-06-14
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-04 | Netherlands | Acceptable 2023-08-22
|
2023-08-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-27 | Netherlands | Acceptable | 2023-12-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-12-20 | Netherlands | Acceptable | 2023-12-20 |