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

NCT ID: NCT07217860

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2029-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Depression Bipolar I Disorder Bipolar Disorder Bipolar II Disorder

Keywords

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Bipolar XEN1101 Azetukalner

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azetukalner 20 mg

Group Type EXPERIMENTAL

Azetukalner

Intervention Type DRUG

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

Interventions

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Azetukalner

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xenon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Woodland International Research Group

Little Rock, Arkansas, United States

Site Status

Woodland Research Northwest

Rogers, Arkansas, United States

Site Status

Clinical Neuroscience Solutions

Orlando, Florida, United States

Site Status

Clinical Neuroscience Solutions Memphis

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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https://www.clinicaltrials.gov/study/NCT07172516?intr=XEN1101&page=2&rank=13

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) (X-CEED)

Other Identifiers

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XPF-010-B302

Identifier Type: -

Identifier Source: org_study_id