An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)

Conditions

• Bipolar Depression
• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

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-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.

Key Dates

First listed

Oct 20, 2025

Start date

Oct 30, 2025

Status verified

Jun 2026

Primary completion

Jun 30, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

400 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 (20)

Find similar trials in Little Rock, AR

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