Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Intervention C Daridorexant · 1 trial · 1 indication
A change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).
| Arm | Type | Description |
|---|---|---|
| Intervention C Daridorexant | EXPERIMENTAL | - |
| Intervention C Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Intervention C Daridorexant | DRUG | Daridorexant will be administered 50 mg once daily at least 2 hours after the last meal and within 30 minutes of going to bed. |
| Intervention C Placebo | DRUG | A matching placebo will be administered at 50 mg daily in the same regimen as the intervention. |
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 narcolep...
Intervention C Daridorexant is an investigational small molecule being studied for the treatment of Post Traumatic Stress Disorder (PTSD). It is currently in Phase 2 clinical development as part of a Department of Defense PTSD Adaptive Platform Trial, with the goal of evaluating its safety and efficacy in patients with this condition.
Intervention C Daridorexant is being developed by Adaptive Biotechnologies Corporation, a company publicly traded under the ticker symbol ADPT. The company is conducting a Phase 2 clinical trial to evaluate this investigational drug for the treatment of Post Traumatic Stress Disorder.
Intervention C Daridorexant is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to assess the drug's potential in treating Post Traumatic Stress Disorder.
Intervention C Daridorexant is being evaluated in a single Phase 2 clinical trial with the identifier NCT05948540. This trial is titled 'Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant' and is currently recruiting participants in the United States. The study is randomized, double-blind, and placebo-controlled, with an enrollment target of 200 participants.
Intervention C Daridorexant is the name used for the drug daridorexant within the context of the Department of Defense PTSD Adaptive Platform Trial. The drug is being studied under this intervention-specific designation in the clinical trial, and it is the same investigational compound being evaluated for Post Traumatic Stress Disorder.