A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Placebo; Drug: JZP150

Study type: Interventional

Funder types: Industry

Identifiers

NCT05178316

JZP150-201

Details and patient eligibility

About

This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP150 in the treatment of adult participants with post-traumatic stress disorder (PTSD).

Full description

JZP150 is an oral, highly selective inhibitor of fatty acid amide hydrolase (FAAH). In this phase 2 study, participants with PTSD will receive either placebo or 1 of 2 doses of JZP150. The primary objective of the study will assess the change in PTSD symptoms from baseline to Week 12 using the Clinician Administered PTSD Scale (CAPS-5).

Enrollment: 282 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged 18 to 70 years
• Participants must be outpatients with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) defined PTSD confirmed by the clinical interview
• PTSD is primary diagnosis

Exclusion criteria

• Acute or unstable medical condition, behavioral or psychiatric disorder (other than PTSD)
• Suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months
• Ongoing traumatic event or exposure to a traumatic event <3 months prior to Screening
• Index event > 12 years
• Index event is combat trauma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 3 patient groups, including a placebo group

JZP150 0.3 mg

Experimental group

Description:

Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.

Treatment:

Drug: JZP150

JZP150 4.0 mg

Experimental group

Description:

Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.

Treatment:

Drug: JZP150

Placebo

Placebo Comparator group

Description:

Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.

Treatment:

Drug: Placebo