Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
Amyotrophic lateral sclerosis (ALS)
Key facts
- Sponsor
- Quralis Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 11 Nov 2024 → 22 Aug 2025
- Decision date (initial)
- 2024-10-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
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 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Quralis Corp.
- Sponsor organisation
- Quralis Corp.
- Address
- 35 Cambridge Park Drive
- City
- Cambridge
- Postcode
- 02140-2325
- Country
- United States
Scientific contact point
- Organisation
- Quralis Corp.
- Contact name
- Doug Williamson, MD
Public contact point
- Organisation
- Quralis Corp.
- Contact name
- Principal Investigator Prof. dr. Leonard van den Berg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
ALS Centrum, Divisie Hersenen, Heidelberglaan 100, 3584 CX, Utrecht
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-11-11 | 2025-08-22 | 2024-11-11 | 2025-07-22 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | Netherlands | Acceptable with conditions 2024-10-07
|
2024-10-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-21 | Netherlands | Acceptable with conditions 2024-10-07
|
2024-10-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-24 | Netherlands | Acceptable with conditions 2024-10-07
|
2024-10-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-29 | Netherlands | Acceptable with conditions 2024-10-07
|
2024-10-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Netherlands | Acceptable 2025-02-17
|
2025-02-20 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-21 | Netherlands | Acceptable 2025-02-17
|
2025-03-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-24 | Netherlands | Acceptable | 2025-05-01 |