drugset / Trial / NCT05941442
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams \[mg\] twice daily \[BID\]) compared with placebo in participants with panic disorder.
Timeline
- Start
- 2023-07-31
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
Outcome
Missed primary endpoint
Stopped (Enrollment): “Sponsor terminated due to significant enrollment and study design challenges”
registry analysis (superiority test); Placebo vs Darigabat 25 mg BID; p = 0.7488; Difference in proportion of participants -0.06 (95% CI -0.33 to 0.23); Fisher Exact; NCT05941442 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darigabat | Small molecule | 25 mg | Oral |