Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
64
Countries
1
Sites
1
Chronic pain, refractory epilepsy, and other neurological disorders of excitation/inhibition (E/I) imbalance within neuronal circuits.
Key facts
- Sponsor
- Axonis Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic pain, refractory epilepsy, and other neurological disorders of excitation/inhibition (E/I) imbalance within neuronal circuits.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Axonis Therapeutics Inc.
- Sponsor organisation
- Axonis Therapeutics Inc.
- Address
- 75 Kneeland Street Fl 14
- City
- Boston
- Postcode
- 02111-1901
- Country
- United States
Scientific contact point
- Organisation
- Axonis Therapeutics Inc.
- Contact name
- Shane Hegarty
Public contact point
- Organisation
- Axonis Therapeutics Inc.
- Contact name
- Megan Johnson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Pain, Zernikedreef 8, 2333 CL, Leiden
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-05-11 | Netherlands | Acceptable 2026-06-26
|
2026-06-26 |