drugset / Trial / NCT07759128
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2026-07-28
- Primary completion
- 2028-12-06
- Completion
- 2028-12-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ulotaront | Small molecule | 50 mg | Oral |
| Subject | Ulotaront | Small molecule | 75 mg | Oral |