drugset / Trial / NCT05178316
A Study of JZP150 in Adults With Posttraumatic Stress Disorder
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JZP150 | Unknown | 0.3 mg | Oral |
| Subject | JZP150 | Unknown | 4 mg | Oral |