Frontlight ResearchEarly access
SuspendedPhase 2
Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
Key facts
- Who runs it
- Global Coalition for Adaptive Research
- Where
- Atlanta, Bethesda, Fort Belvoir, Fort Thomas, Joint Base Lewis McChord, Miami, San Antonio, Tripler AMC, and Williamsville, United StatesSee the 9 sites
- Trial code
- Status
- Suspended
- Phase
- Phase 2
- People taking part
- 200 people, planned
- Started
- 2 Nov 2023
- Expected to end
- Jul 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Intervention C Daridorexant
- Intervention C Placebo
- Record updated
- 30 June 2026
- Why it stopped
- The trial has been temporarily suspended due to administrative issues
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612)
Who cannot take part
- History of any treatment with daridorexant
- History of narcolepsy
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612)
Where in United States
- Advanced Discovery ResearchAtlanta, United States
- Walter Reed National Military Medical Center (WRNMC)Bethesda, United States
- Alexander T. Augusta Military Medical Center (ATAMMC):Fort Belvoir, United States
- Cincinnati Veteran's Affairs Medical CenterFort Thomas, United States
- Madigan Army Medical CenterJoint Base Lewis McChord, United States
- Homestead Associates in Research Inc.Miami, United States
- Wilford Hall Ambulatory Surgical Center (WHASC)San Antonio, United States
- Tripler Army Medical Center (TAMC)Tripler AMC, United States
- Upstate Clinical Research Associates, LLCWilliamsville, United States
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Intervention C DaridorexantTreatment being tested
- Intervention C PlaceboPlacebo, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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, Veterans, and Non-Veteran Civilians With PTSD
- Record updated
- 30 June 2026