Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
59
Countries
4
Sites
7
Amyotrophic lateral sclerosis
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
- 15 Aug 2023 → ongoing
- Decision date (initial)
- 2023-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-500758-41-00
- ClinicalTrials.gov
- NCT05633459
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
Quralis Corp.
- Sponsor organisation
- Quralis Corp.
- Address
- 1209 North Orange Street
- City
- Wilmington
- Postcode
- 19801-1120
- Country
- United States
Scientific contact point
- Organisation
- Quralis Corp.
- Contact name
- Bryan Boggs
Public contact point
- Organisation
- Quralis Corp.
- Contact name
- Bryan Boggs
Locations
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 9 | 1 |
| Germany | Ongoing, recruitment ended | 11 | 4 |
| Ireland | Ongoing, recruitment ended | 6 | 1 |
| Netherlands | Ongoing, recruitment ended | 9 | 1 |
| Rest of world
United Kingdom, Canada
|
— | 24 | — |
Investigational sites
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Neurodegenerative Erkrankung, Venusberg-Campus 1/99, Venusberg, Bonn
University Medical Centre Schleswig-Holstein
Campus Lübeck, Neurologie, Ratzeburger Allee 160, 23538, Lübeck
Universitatsklinikum Ulm AöR
Neurology, Oberer Eselsberg 45, Eselsberg, Ulm
Charite Research Organisation GmbH
Neurologie, Neurochirurgie und Psychiatrie, Chariteplatz 1, Mitte, Berlin
University Medical Center Utrecht
Neurology, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-02-19 | 2025-02-19 | 2025-08-14 | ||
| Germany | 2023-08-16 | 2023-08-17 | 2025-08-14 | ||
| Ireland | 2023-08-15 | 2023-08-28 | 2025-08-14 | ||
| Netherlands | 2023-08-15 | 2023-08-17 | 2025-08-14 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-31 | Germany | Acceptable with conditions 2023-05-22
|
2023-05-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-06-09 | Germany | Acceptable with conditions 2023-05-22
|
2023-06-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-06-23 | Germany | Acceptable with conditions 2023-05-22
|
2023-06-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-12 | 2023-06-30 | Acceptable with conditions | 2023-08-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-13 | 2023-06-30 | Acceptable with conditions | 2023-07-19 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-14 | 2023-06-30 | Acceptable with conditions | 2023-08-01 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-15 | 2023-06-30 | Germany | Acceptable with conditions | 2023-09-18 |
| 8 | SUBSTANTIAL MODIFICATION | SM-16 | 2024-06-12 | Germany | Acceptable 2024-09-12
|
2024-09-12 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-24 | Acceptable 2024-09-12
|
2024-09-24 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-17 | 2024-09-27 | Acceptable 2025-01-13
|
2025-01-13 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-01-27 | Germany | Acceptable 2025-01-29
|
2025-01-29 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-31 | Acceptable 2025-01-29
|
2025-01-31 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-01-31 | Germany | Acceptable | 2025-02-06 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-02-07 | Germany | 2025-02-07 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-02-19 | Germany | 2025-02-19 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-05-16 | Germany | Acceptable 2025-08-06
|
2025-08-07 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-09-01 | Acceptable 2025-08-06
|
2025-09-01 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-21 | 2025-10-30 | Acceptable | 2025-12-15 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-22 | 2026-01-30 | Germany | Acceptable 2026-02-27
|
2026-03-04 |