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

Global Coalition for Adaptive Research

Status and phase: Enrolling; Phase 2

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Intervention C Placebo; Drug: Intervention C Daridorexant

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT05948540

S-21-02 (Daridorexant)

Details and patient eligibility

About

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.

Full 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 complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV_8eTQKw6TNug4z42.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Intervention C Daridorexant

Experimental group

Treatment:

Drug: Intervention C Daridorexant

Intervention C Placebo

Placebo Comparator group

Treatment:

Drug: Intervention C Placebo