Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Parkinson's Disease
Key facts
- Sponsor
- Nodthera Limited
- 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
- 12 Apr 2023 → 18 Dec 2023
- Decision date (initial)
- 2023-04-12
- 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 |
|---|---|---|---|---|
| 21.1 | LLT | 10013113 | Disease Parkinson's | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nodthera Limited
- Sponsor organisation
- Nodthera Limited
- Address
- Mansion House, Chesterford Park, Little Chesterford Chesterford Park Little Chesterford
- City
- Saffron Walden
- Postcode
- CB10 1XL
- Country
- United Kingdom
Scientific contact point
- Organisation
- Nodthera Limited
- Contact name
- Sarah Director
Public contact point
- Organisation
- Nodthera Limited
- Contact name
- Sarah Director
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 14 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
QPS Netherlands B.V.
Clinical Pharmacology, Hanzeplein 1, 9713 GZ, 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 | 2023-04-12 | 2023-12-18 | 2023-04-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-13 | Netherlands | Acceptable 2023-04-12
|
2023-04-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-05 | Netherlands | Acceptable 2023-04-12
|
2023-07-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-05 | Netherlands | Acceptable 2023-07-19
|
2023-07-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-09-11 | Netherlands | Acceptable 2023-07-19
|
2023-09-11 |