Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
120
Countries
1
Sites
1
Not applicable
Key facts
- Sponsor
- Neurotrauma Sciences LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 6 Jun 2025 → 7 Apr 2026
- Decision date (initial)
- 2025-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Not applicable
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neurotrauma Sciences LLC
- Sponsor organisation
- Neurotrauma Sciences LLC
- Address
- 2655 Northwinds Parkway Suite 5c
- City
- Alpharetta
- Postcode
- 30009-2280
- Country
- United States
Scientific contact point
- Organisation
- Neurotrauma Sciences LLC
- Contact name
- -
Public contact point
- Organisation
- Neurotrauma Sciences LLC
- Contact name
- -
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 120 | 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 |
|---|---|---|---|---|---|
| Belgium | 2025-06-06 | 2026-04-07 | 2025-06-06 | 2026-03-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-10 | Belgium | Acceptable 2025-04-30
|
2025-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-06 | Belgium | Acceptable 2025-11-21
|
2025-11-26 |