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, Veterans, and Non-Veteran Civilians With PTSD
Global Coalition for Adaptive Research
Summary
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Intervention C - Daridorexant will assess the safety and efficacy of daridorexant in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.
Description
The general structure of this Adaptive Platform Trial (APT) consists of a 30-day Screening Period, a 12-week Platform Treatment Period, and a 4-week Safety Follow-up. The S-21-02 Platform Trial will evaluate the safety and efficacy of multiple investigational products for the treatment of PTSD (see NCT05422612 for Master Protocol information). Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). This record only includes information…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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.
Interventions
- DrugIntervention C Daridorexant
Daridorexant will be administered 50 mg once daily at least 2 hours after the last meal and within 30 minutes of going to bed.
- DrugIntervention C Placebo
A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.
Locations (9)
- Homestead Associates in Research, Inc.Miami, Florida
- Advanced Discovery ResearchAtlanta, Georgia
- Tripler Army Medical Center (TAMC)Tripler AMC, Hawaii
- Cincinnati Veteran's Affairs Medical CenterFort Thomas, Kentucky
- Walter Reed National Military Medical Center (WRNMC)Bethesda, Maryland
- Upstate Clinical Research Associates, LLCWilliamsville, New York