Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
210
Countries
1
Sites
1
Multiple Sclerosis
Key facts
- Sponsor
- Neuraxpharm Pharmaceuticals S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 21 Aug 2024 → 23 Dec 2024
- Decision date (initial)
- 2024-03-15
- 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
Multiple Sclerosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neuraxpharm Pharmaceuticals S.L.
- Sponsor organisation
- Neuraxpharm Pharmaceuticals S.L.
- Address
- Avinguda De Barcelona 69, Poligono Industrialde La Fuensanta Poligono Industrialde La Fuensanta
- City
- Sant Joan Despi
- Postcode
- 08970
- Country
- Spain
Scientific contact point
- Organisation
- Neuraxpharm Pharmaceuticals S.L.
- Contact name
- Emili González-Pérez
Public contact point
- Organisation
- Neuraxpharm Pharmaceuticals S.L.
- Contact name
- Emili González-Pérez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 210 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-08-21 | 2024-12-23 | 2024-08-22 | 2024-11-04 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-07 | Portugal | Acceptable with conditions 2024-03-15
|
2024-03-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-05 | Portugal | Acceptable 2024-07-02
|
2024-07-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-04 | Acceptable 2024-07-02
|
||
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-13 | Portugal | Acceptable | 2025-03-07 |