Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
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
Global Coalition for Adaptive Research
200 participants
Nov 2, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Exclusion Criteria2
- History of narcolepsy.
- History of any treatment with daridorexant.
Interventions
Daridorexant will be administered 50 mg once daily at least 2 hours after the last meal and within 30 minutes of going to bed.
A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05948540