An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Public ClinicalTrials.gov record NCT07217860. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression
Study identification
- NCT ID
- NCT07217860
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Industry
- Enrollment
- 400 participants
Conditions and interventions
Interventions
- Azetukalner Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2025
- Primary completion
- May 31, 2029
- Completion
- Jul 31, 2029
- Last update posted
- Apr 2, 2026
2025 – 2029
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| PharmaSouth Research, LLC | Coral Gables | Florida | 33146 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | — |
| Synexus Clinical Research, Inc. | Atlanta | Georgia | 30328 | — |
| CenExel iResearch | Decatur | Georgia | 30030 | — |
| Denali Health Atlanta, LLC | Stone Mountain | Georgia | 30083 | — |
| Lumina Clinical Research Center | Cherry Hill | New Jersey | 92866 | — |
| Neurobehavioral Research Inc | Cedarhurst | New York | 11516 | — |
| Clinical Neuroscience Solutions Memphis | Memphis | Tennessee | 38119 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07217860, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2026 · Synced May 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07217860 live on ClinicalTrials.gov.