Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
Purpose
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.
Condition
- Post Traumatic Stress Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Daridorexant is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The overall 2-stage randomization scheme will be implemented by an unblinded statistician who is otherwise uninvolved in study operations. Participants will be assigned a study number at Screening (Subject ID). In the first stage of randomization, eligible participants who complete screening will be randomly assigned to an open platform cohort for which they are eligible (both site PIs and participants are aware of the cohort assignment) and, within that cohort, the second stage of randomization is to intervention vs placebo (double-blind) using Interactive Response Technology (IRT). For this APT, participant assignment to a cohort will not be blinded. The tablets/capsules used in the cohorts may not be visually similar between cohorts and blinding to cohort assignment is not necessary to avoid bias. However, within each cohort, participants, site personnel, contract research personnel and the sponsor will be blind to treatment assignment (intervention vs. placebo).
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention C Daridorexant |
|
|
|
Placebo Comparator Intervention C Placebo |
|
Recruiting Locations
Miami, Florida 33032
Atlanta, Georgia 30318
Tripler AMC, Hawaii 96859
Department of Clinical Investigation
808-304-1143
dha.tripler.tripler-amc.mbx.ci-study@health.mil
Fort Thomas, Kentucky 41075
Bethesda, Maryland 20889-5632
Williamsville, New York 14221
San Antonio, Texas 78236
Fort Belvoir, Virginia 22060-5285
Joint Base Lewis McChord, Washington 98433
More Details
- NCT ID
- NCT05948540
- Status
- Recruiting
- Sponsor
- Global Coalition for Adaptive Research
Detailed 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 of 5:3; intervention:placebo), for the duration of the 12-week treatment period. Parties interested in having their intervention considered for testing within the M-PACT should contact partners@gcaresearch.org