An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Condition(s) studied
Investigational drug(s) / intervention(s)
Azetukalner: Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | |
| Woodland Research Northwest | Rogers | Arkansas | |
| Clinical Innovations, Inc, dba CITrials | Bellflower | California | |
| ProScience Research Group | Culver City | California | |
| Clinical Innovations, Inc | Riverside | California | |
| PharmaSouth Research, LLC | Coral Gables | Florida | |
| Clinical Neuroscience Solutions, LLC | Jacksonville | Florida | |
| Central Miami Medical Institute | Miami | Florida | |
| Clinical Neuroscience Solutions, LLC | Orlando | Florida | |
| Synexus Clinical Research, Inc. | Atlanta | Georgia | |
| Atlanta Center for Medical Research | Atlanta | Georgia | |
| CenExel iResearch | Decatur | Georgia | |
| Denali Health Atlanta, LLC | Stone Mountain | Georgia | |
| Advanced Quality Medical Research | Orland Park | Illinois | |
| Lumina Clinical Research Center | Cherry Hill | New Jersey | |
| Neurobehavioral Research Inc | Cedarhurst | New York | |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | |
| Clinical Neuroscience Solutions, LLC | Memphis | Tennessee | |
| Grayline Research Center | Wichita Falls | Texas | |
| Core Clinical Research | Everett | Washington |
More Xenon Pharmaceuticals Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07217860 on ClinicalTrials.gov ↗ ← All trials in the USA