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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
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
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)
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CenExel iResearch
Decatur, Georgia, United States
Lumina Clinical Research Center
Cherry Hill, New Jersey, United States
Clinical Neuroscience Solutions Memphis
Memphis, Tennessee, United States