Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
16
Countries
2
Sites
3
FRONTOTEMPORAL DEMENTIA (FTD)
Key facts
- Sponsor
- Passage Bio Inc.
- 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 Feb 2024 → 7 May 2026
- Decision date (initial)
- 2023-10-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507724-23-00
- EudraCT number
- 2020-004499-17
- ClinicalTrials.gov
- NCT04747431
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
FRONTOTEMPORAL DEMENTIA (FTD)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Passage Bio Inc.
- Sponsor organisation
- Passage Bio Inc.
- Address
- 2005 Market Street Floor 39th
- City
- Philadelphia
- Postcode
- 19103-7026
- Country
- United States
Scientific contact point
- Organisation
- Passage Bio Inc.
- Contact name
- Clinical Information Desk
Public contact point
- Organisation
- Passage Bio Inc.
- Contact name
- Clinical Information Desk
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 2 | 1 |
| Spain | Ended | 2 | 2 |
| Rest of world
United States, Brazil, Canada
|
— | 12 | — |
Investigational sites
Unidade Local De Saude De Coimbra E.P.E.
Servico de Neurologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
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 |
|---|---|---|---|---|---|
| Portugal | 2024-02-01 | 2025-02-12 | 2026-05-07 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-31 | Portugal | Acceptable 2023-09-28
|
2023-10-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-17 | Portugal | Acceptable 2023-12-13
|
2023-12-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-05 | Portugal | Acceptable 2023-12-13
|
2024-04-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-04 | Portugal | Acceptable 2025-02-24
|
2025-02-25 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-04 | Portugal | Acceptable 2025-02-24
|
2025-03-04 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-03-13 | Acceptable 2025-02-24
|
2025-06-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-31 | Portugal | Acceptable 2025-09-15
|
2025-09-16 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-15 | Portugal | Acceptable 2025-09-15
|
2026-05-15 |