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A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. to Otsuka Pharmaceutical Development & Commercialization, Inc. Trial sites expanded: 3 → 6 locations · Eligibility criteria expanded, about 17 words · Secondary endpoints: details revised at 1 of 2 entries Show 3 more changesShow less
    • Trial sites expanded: 3 → 6 locations
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Astex Pharmaceuticals
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This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.
Trial Details
NCT Number NCT07759128
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Generalized Anxiety Disorder
Enrollment 576 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov