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Enrolling by invitation NCT07217860

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

Phase III Interventional Bipolar Depression Bipolar I Disorder Bipolar Disorder Bipolar II Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Azetukalner.
Who it may be relevant to
Registry conditions: Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time [Time frame: From baseline through the active extension treatment (Week 52)]
  • Change in Clinical Global Impression of Severity (CGI-S) score over time [Time frame: From baseline through the active extension treatment (Week 52)]
  • Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time [Time frame: From baseline through the active extension treatment (Week 52)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 15 centers
  • Woodland International Research Group — Little Rock
  • Woodland Research Northwest — Rogers
  • ProScience Research Group — Culver City
  • PharmaSouth Research, LLC — Coral Gables
  • Clinical Neuroscience Solutions, Inc. — Jacksonville
  • Clinical Neuroscience Solutions — Orlando
  • Synexus Clinical Research, Inc. — Atlanta
  • CenExel iResearch — Decatur
  • … and 7 more centers

Identifiers

NCT: NCT07217860 · XPF-010-B302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗