Clinical trial NCT05948540: Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
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 and Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Global Coalition for Adaptive Research
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: PPD Development, LP
name: Berry Consultants
name: Idorsia Pharmaceuticals Ltd.
name: Cambridge Cognition Ltd
name: Citeline
First posted: 2023-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Daridorexant is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
timeFrame: 12 Weeks
measure: Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Frequency of treatment-emergent adverse events (TEAEs).
timeFrame: 12 Weeks
measure: Severity of treatment-emergent adverse events (TEAEs).
timeFrame: 12 Weeks
measure: Frequency of serious adverse events (SAEs)
timeFrame: 12 Weeks
measure: Severity of serious adverse events (SAEs).
timeFrame: 12 Weeks
measure: Relative change from Baseline to Week 12 in CAPS-5-R, Past Month total score.
timeFrame: 12 Weeks
measure: Number of participants with a Response Rate ≥30%
timeFrame: 12 Weeks
measure: Number of participants with a Response Rate ≥50%
timeFrame: 12 Weeks
measure: Number of participants Achieving Remission.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Healthcare System
state: Arizona
city: Miami
country: United States
facility: Homestead Associates in Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Advanced Discovery Research
state: Georgia
city: Fort Thomas
country: United States
facility: Cincinnati Veteran's Affairs Medical Center
state: Kentucky
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: San Antonio
country: United States
facility: Wilford Hall Ambulatory Surgical Center (WHASC)
state: Texas
city: Joint Base Lewis McChord
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References:
citation: Viele K. Allocation in platform trials to maintain comparability across time and eligibility. Stat Med. 2023 Jul 20;42(16):2811-2818. doi: 10.1002/sim.9750. Epub 2023 Apr 23.