Trials / Enrolling By Invitation
Enrolling By InvitationNCT06922110
An Open-Label Study of Azetukalner in Major Depressive Disorder
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder
- Status
- Enrolling By Invitation
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- Sponsor
- Xenon Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azetukalner | Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks. |
Timeline
- Start date
- 2025-03-18
- Primary completion
- 2027-01-01
- Completion
- 2027-03-01
- First posted
- 2025-04-10
- Last updated
- 2026-02-03
Locations
49 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06922110. Inclusion in this directory is not an endorsement.