U.S., Oct. 21 -- ClinicalTrials.gov registry received information related to the study (NCT07217860) titled 'An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)' on Oct. 14.
Brief Summary: 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.
Study Start Date: Oct., 2025
Study Type: INTERVENTIONAL
Condition:
Bipolar Depression
Bipolar I Disorder
Bipolar Disorder
Bipolar II Disorder
Intervention:
DRUG: Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Recruit...