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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07217860
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
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 30, 2025 (Actual)
- Primary completion
- Jun 2029 (Estimated)
- Completion
- Aug 2029 (Estimated)
- Last update posted
- Oct 13, 2026
2025 – 2029
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| Clinical Innovations, Inc, dba CITrials | Bellflower | California | 90706 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Clinical Innovations, Inc | Riverside | California | 92506 | — |
| PharmaSouth Research, LLC | Coral Gables | Florida | 33146 | — |
| Clinical Neuroscience Solutions, LLC | Jacksonville | Florida | 32256 | — |
| Central Miami Medical Institute | Miami | Florida | 33125 | — |
| Clinical Neuroscience Solutions, LLC | Orlando | Florida | 32801 | — |
| Synexus Clinical Research, Inc. | Atlanta | Georgia | 30328 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| CenExel iResearch | Decatur | Georgia | 30030 | — |
| Denali Health Atlanta, LLC | Stone Mountain | Georgia | 30083 | — |
| Advanced Quality Medical Research | Orland Park | Illinois | 60462 | — |
| Lumina Clinical Research Center | Cherry Hill | New Jersey | 92866 | — |
| Neurobehavioral Research Inc | Cedarhurst | New York | 11516 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18103 | — |
| Clinical Neuroscience Solutions, LLC | Memphis | Tennessee | 38119 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
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 Oct 13, 2026 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07217860 live on ClinicalTrials.gov.