Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
48
Countries
1
Sites
1
Epilepsy, amotrophic lateral sclerosis, neuropathy
Key facts
- Sponsor
- Quralis Corp.
- 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
- 2 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-23
- 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
Epilepsy, amotrophic lateral sclerosis, neuropathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
| 21.0 | PT | 10015037 | Epilepsy | 100000004852 |
| 28.0 | LLT | 10029328 | Neuropathy | 10029205 |
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
- Tom Bowman
Public contact point
- Organisation
- Quralis Corp.
- Contact name
- Principal Investigator Salah Hadi
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2026-02-02 | 2026-02-02 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-24 | Netherlands | Acceptable 2026-01-22
|
2026-01-23 |