Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
80
Countries
3
Sites
5
Parkinson's Disease
Key facts
- Sponsor
- H. Lundbeck A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 22 Jul 2024 → 12 Feb 2026
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507785-12-00
- ClinicalTrials.gov
- NCT04291859
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
H. Lundbeck A/S
- Sponsor organisation
- H. Lundbeck A/S
- Address
- Ottiliavej 9
- City
- Valby
- Postcode
- 2500
- Country
- Denmark
Scientific contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- H. Lundbeck A/S
Public contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- H. Lundbeck A/S
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 4 | 1 |
| Germany | Ended | 20 | 1 |
| Spain | Ended | 30 | 3 |
| Rest of world
United States
|
— | 26 | — |
Investigational sites
Centre Hospitalier Universitaire De Caen Normandie
Neurology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari General De Catalunya
Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Universitari Vall D Hebron
Neurology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 |
|---|---|---|---|---|---|
| France | 2025-01-17 | 2026-01-05 | 2025-07-31 | 2025-09-10 | |
| Germany | 2024-07-22 | 2026-02-12 | 2024-08-19 | 2025-09-10 | |
| Spain | 2024-08-08 | 2026-01-28 | 2024-10-02 | 2025-09-10 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Germany | Acceptable with conditions 2024-05-23
|
2024-05-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-26 | Germany | Acceptable with conditions 2024-05-23
|
2024-06-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-24 | Germany | Acceptable with conditions 2024-05-23
|
2024-07-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-04 | Germany | Acceptable 2025-01-13
|
2025-01-13 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-18 | Acceptable 2025-01-13
|
2025-03-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-20 | Germany | Acceptable | 2025-04-09 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-20 | Acceptable | 2025-04-15 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-16 | Acceptable | 2025-05-16 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-04 | Germany | Acceptable | 2025-07-04 |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-15 | Germany | Acceptable | 2025-10-01 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-21 | Germany | Acceptable | 2025-10-21 |