RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Post Traumatic Stress Disorder
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix VA Healthcare System, Phoenix, Arizona, United States, 85012-1839

Miami

Homestead Associates in Research, Inc., Miami, Florida, United States, 33032

Atlanta

Advanced Discovery Research, Atlanta, Georgia, United States, 30318

Tripler AMC

Tripler Army Medical Center (TAMC), Tripler AMC, Hawaii, United States, 96859

Fort Thomas

Cincinnati Veteran's Affairs Medical Center, Fort Thomas, Kentucky, United States, 41075

Williamsville

Upstate Clinical Research Associates, LLC, Williamsville, New York, United States, 14221

San Antonio

Wilford Hall Ambulatory Surgical Center (WHASC), San Antonio, Texas, United States, 78236

Joint Base Lewis McChord

Madigan Army Medical Center, Joint Base Lewis McChord, Washington, United States, 98433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. History of narcolepsy.
  • 2. History of any treatment with daridorexant.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Global Coalition for Adaptive Research,

Study Record Dates

2026-09