Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
58
Countries
5
Sites
9
Amyotrophic Lateral Sclerosis
Key facts
- Sponsor
- Verge Genomics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Mar 2024 → 5 Aug 2025
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Amyotrophic Lateral Sclerosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Verge Genomics
- Sponsor organisation
- Verge Genomics
- Address
- 131 Oyster Point Boulevard Suite 300
- City
- South San Francisco
- Postcode
- 94080-2032
- Country
- United States
Scientific contact point
- Organisation
- Verge Genomics
- Contact name
- Sujata Sankar
Public contact point
- Organisation
- Verge Genomics
- Contact name
- Sujata Sankar
Locations
5 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 8 | 1 |
| Finland | Ended | 15 | 4 |
| Netherlands | Ended | 8 | 1 |
| Spain | Ended | 8 | 2 |
| Sweden | Not authorised | 8 | 1 |
| Rest of world
Canada
|
— | 11 | — |
Investigational sites
Turku University Hospital
Neurology, Hameentie 11, 20520, Turku
Tampere University Hospital
Neuromuscular Research center, Biokatu 12 5 6, 33520, Tampere
University Of Eastern Finland
Brain research unit, P. O. Box 1627, 70211, Kuopio
Meilahti Hospital
Neurocenter, P. O. Box 340, 00029, Helsinki
Universitair Medisch Centrum Utrecht
Neurology, Heidelberglaan 100, 3584 CX, Utrecht
Hospital Universitario Regional De Malaga
Neurology, Avenida De Carlos De Haya Sn, 29010, Malaga
Bellvitge University Hospital
Neurology, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
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 | 2024-04-17 | 2024-04-25 | 2024-08-05 | ||
| Finland | 2024-04-24 | 2024-04-25 | 2024-07-04 | ||
| Netherlands | 2024-03-08 | 2024-03-11 | 2024-08-16 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-15 | Netherlands | Acceptable 2024-01-22
|
2024-01-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-31 | Netherlands | Acceptable | 2024-02-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-31 | Acceptable | 2024-02-28 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-31 | Acceptable | 2024-03-11 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-02-02 | Acceptable | 2024-03-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-04-09 | Netherlands | No conclusion 2024-05-28
|
2024-05-29 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-17 | No conclusion 2024-05-28
|
2024-06-17 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-08-29 | Netherlands | Acceptable 2024-10-21
|
2024-10-22 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-04 | Netherlands | Acceptable 2024-10-21
|
2024-12-04 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-01-08 | Netherlands | Acceptable 2025-03-17
|
2025-03-17 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-14 | Acceptable 2025-03-17
|
2025-07-14 |