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

Xenon Pharmaceuticals

Status and phase

Invitation-only

Phase 3

Conditions

Bipolar II Disorder

Bipolar I Disorder

Bipolar Disorder

Bipolar Depression

Treatments

Drug: Azetukalner

Study type

Interventional

Funder types

Industry

Identifiers

NCT07217860

XPF-010-B302

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression.
Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
Participant is willing to comply with the contraception requirements.

Exclusion criteria

Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
Participant is pregnant, breastfeeding, or planning to become pregnant.
Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for the treatment of any medical condition during the study or within 28 days after completion of this study.
Participant is judged by the investigator to have a significant risk for self-harm or suicidal behavior during their participation in the study or is considered to be an imminent danger to themself or others.