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Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

Post Traumatic Stress Disorder Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 relevant to the daridorexant cohort. Once a participant meets all eligibility criteria for the Master Protocol, eligibility for each currently enrolling intervention cohort is assessed. Eligible participants will be randomized with equal probability into a cohort. Participants randomized to the daridorexant cohort are then randomly assigned to receive either daridorexant or placebo in a ratio defined by the number of cohorts for which they are eligible, for the duration of the 12-week treatment period. Parties interested in having their intervention considered for testing within the DOD PTSD APT should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV_0oDoJXvIL7EFM1M. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05948540
Study type Interventional
Source U.S. Army Medical Research and Development Command
Contact Dr. Kimberly del Carmen
Phone Please reach out by email
Email kimberly.a.delcarmen.civ@health.mil
Status Recruiting
Phase Phase 2
Start date November 2, 2023
Completion date September 2026
View Details
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