An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
NCT07217860Phase 3Active, not recruiting
- Lead sponsor
- Xenon Pharmaceuticals Inc. (Industry)
- Enrollment
- 400 (estimated)
- Start date
- 30 Oct 2025
- Primary completion
- Jun 2029 (estimated)
- Study completion
- 1 Aug 2029
- Last update posted
- 13 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- Azetukalner Drug
Conditions and primary outcome
- Bipolar Depression
- Bipolar I Disorder
- Bipolar Disorder
- Bipolar II Disorder
Primary outcome
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest (From the start of treatment in the open-label extension study through 8 weeks after the last dose)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07217860.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07217860 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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