An Open-Label Study of Azetukalner in Major Depressive Disorder

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Azetukalner — DRUG
  Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.

Study Details

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).

Key Dates

Start date

Mar 18, 2025

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

460 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Azetukalner 20 mg

Primary Outcome Measure

Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest [ Time Frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose ]

Locations (63)

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