Daridorexant for post-traumatic stress disorder in an adaptive platform
A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PTSD
This study will try daridorexant to see if it helps adults with post-traumatic stress disorder sleep better and reduce symptoms compared with placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Global Coalition for Adaptive Research Academic / other |
| Locations | 10 sites (Phoenix, Arizona and 9 other locations) |
| Trial ID | NCT05948540 on ClinicalTrials.gov |
What this trial studies
This Phase 2 randomized, double-blind, placebo-controlled arm uses an adaptive platform design to test daridorexant in adults with PTSD. After a 30-day screening period, eligible participants enter a 12-week treatment period followed by a 4-week safety follow-up. Participants are randomized among multiple cohorts and, within the daridorexant cohort, are assigned to daridorexant or placebo in a 5:3 ratio with shared placebo controls across interventions. This record applies only to the daridorexant cohort and excludes people with a history of narcolepsy or prior daridorexant treatment.
Who should consider this trial
Good fit: Adults who meet the S-21-02 master protocol eligibility, do not have narcolepsy, have no prior daridorexant exposure, and can attend study visits at a participating site are appropriate candidates.
Not a fit: People with a history of narcolepsy, prior treatment with daridorexant, or who do not meet the master protocol criteria would not be eligible and are unlikely to benefit from this arm.
Why it matters
Potential benefit: If successful, daridorexant could improve sleep and may reduce PTSD symptom severity for some patients.
How similar studies have performed: Daridorexant and other orexin receptor antagonists are approved and effective for insomnia, but evidence specifically showing benefit for PTSD symptoms is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612). Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612). 1. History of narcolepsy. 2. History of any treatment with daridorexant.
Where this trial is running
Phoenix, Arizona and 9 other locations
- Phoenix VA Healthcare System — Phoenix, Arizona, United States (Recruiting)
- Homestead Associates in Research, Inc. — Miami, Florida, United States (Recruiting)
- Advanced Discovery Research — Atlanta, Georgia, United States (Recruiting)
- Tripler Army Medical Center (TAMC) — Tripler AMC, Hawaii, United States (Recruiting)
- Cincinnati Veteran's Affairs Medical Center — Fort Thomas, Kentucky, United States (Recruiting)
- Walter Reed National Military Medical Center (WRNMC) — Bethesda, Maryland, United States (Recruiting)
- Upstate Clinical Research Associates, LLC — Williamsville, New York, United States (Recruiting)
- Wilford Hall Ambulatory Surgical Center (WHASC) — San Antonio, Texas, United States (Recruiting)
- Alexander T. Augusta Military Medical Center (ATAMMC): — Fort Belvoir, Virginia, United States (Recruiting)
- Madigan Army Medical Center — Joint Base Lewis McChord, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Please visit the website:
- Phone: ptsdclinicaltrial.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.