Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Amyotrophic Lateral Sclerosis (ALS)
Key facts
- Sponsor
- Mitochon Pharmaceuticals 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 Jul 2024 → ongoing
- Decision date (initial)
- 2023-11-28
- 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
Amyotrophic Lateral Sclerosis (ALS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mitochon Pharmaceuticals Inc.
- Sponsor organisation
- Mitochon Pharmaceuticals Inc.
- Address
- 970 Cross Lane
- City
- Blue Bell
- Postcode
- 19422-1574
- Country
- United States
Scientific contact point
- Organisation
- Mitochon Pharmaceuticals Inc.
- Contact name
- Chief Scientific Officer (CSO)
Public contact point
- Organisation
- Mitochon Pharmaceuticals Inc.
- Contact name
- Chief Scientific Officer (CSO)
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 40 | 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 |
|---|---|---|---|---|---|
| Hungary | 2024-07-01 | 2024-07-02 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-01 | Hungary | Acceptable 2023-11-21
|
2023-11-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-30 | Hungary | Acceptable 2024-05-23
|
2024-06-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-04 | Hungary | Acceptable 2024-09-24
|
2024-09-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-29 | Hungary | Acceptable 2025-07-28
|
2025-08-01 |