drugset / Trial / NCT05178316

A Study of JZP150 in Adults With Posttraumatic Stress Disorder

NCT05178316 ↗

Phase 2 Completed 282 enrolled Jazz Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP150 in the treatment of adult participants with post-traumatic stress disorder (PTSD).

Timeline

Start
2021-12-29
Primary completion
2023-12-05
Completion
2023-12-05

Outcome

Missed primary endpoint

registry analysis (superiority test); JZP150 0.3 mg vs Placebo; p =0.8862; Least squares mean difference 0.31 (95% CI -3.98 to 4.60); Mixed Models Analysis NCT05178316 ↗

registry analysis (superiority test); JZP150 4.0 mg vs Placebo; p =0.6832; Least squares mean difference -0.74 (95% CI -4.32 to 2.84); Mixed Models Analysis NCT05178316 ↗

release “The trial did not meet the primary endpoint.” jazzpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject JZP150 Unknown 0.3 mg Oral
Subject JZP150 Unknown 4 mg Oral