Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
1
Frontotemporal dementia (FTD)
Key facts
- Sponsor
- Vesper Bio ApS, Vesper Bio ApS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Phenomena and Processes [G] - Genetic Phenomena [G05]
- Trial duration
- 11 Dec 2024 → 5 Aug 2025
- Decision date (initial)
- 2024-10-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513258-31-00
- WHO UTN
- U1111-1311-8366
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Frontotemporal dementia (FTD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10068968 | Frontotemporal dementia | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vesper Bio ApS
- Sponsor organisation
- Vesper Bio ApS
- Address
- Scherfigsvej 7
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Vesper Bio ApS
- Contact name
- Mads Kjolby
Public contact point
- Organisation
- Vesper Bio ApS
- Contact name
- Mads Kjolby
Vesper Bio ApS
- Sponsor organisation
- Vesper Bio ApS
- Address
- 4th Floor, Hauser Plads 10 Hauser Plads 10
- City
- Copenhagen K
- Postcode
- 1127
- Country
- Denmark
Scientific contact point
- Organisation
- Vesper Bio ApS
- Contact name
- Mads Kjolby
Public contact point
- Organisation
- Vesper Bio ApS
- Contact name
- Mads Kjolby
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 3 | 1 |
| Rest of world
United Kingdom
|
— | 3 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Neurologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 | 2024-12-11 | 2025-07-08 | 2025-02-17 | 2025-02-25 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | Netherlands | Acceptable 2024-10-28
|
2024-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-27 | Netherlands | Acceptable 2024-12-13
|
2024-12-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-21 | Netherlands | Acceptable 2024-12-13
|
2025-02-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-25 | Netherlands | Acceptable 2024-12-13
|
2025-02-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-04 | Netherlands | Acceptable 2025-03-28
|
2025-04-01 |