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NCT05178316 Clinical Trial

A Study of JZP150 in Adults With Posttraumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

Official title:
A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05178316
Other study ID # JZP150-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 29, 2021
Est. completion date December 5, 2023

Study information
Verified date January 2024
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 282
Est. completion date December 5, 2023
Est. primary completion date December 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• JZP150
Oral administration of JZP150 once daily in the morning
• Placebo
Oral administration of placebo once daily in the morning

Locations
Country Name City State
United States Advanced Discovery Research Atlanta Georgia
United States Austin Clinical Trial Partners Austin Texas
United States Dell Medical School Universityof Texas at Austin Austin Texas
United States Houston Clinical Trials Bellaire Texas
United States Clinical Innovations Inc. Bellflower California
United States Southern California Research, LLC Beverly Hills California
United States Boston Clinical Trial Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States SPRI Clinical Trials Brooklyn New York
United States Sanro Clinical Research Group, LLC Bryant Arkansas
United States American Medical Research, Inc Chicago Illinois
United States MCB Clinical Research Center Colorado Springs Colorado
United States CT Clinical Research Cromwell Connecticut
United States Relaro Medical Trials, LLC Dallas Texas
United States Midwest Clinical Research Center Dayton Ohio
United States CenExel iResearch Decatur Georgia
United States Eastside Therapeutic Resource Everett Washington
United States Northpointe Psychiatry Flower Mound Texas
United States Sarkis Clinical Trials Gainesville Florida
United States Behavioral Research Specialists, LLC Glendale California
United States Clinical Neuroscience Solutions, Inc. Jacksonville Florida
United States Accel Research Sites -Lakeland Clinical Research Unit Lakeland Florida
United States Accel Research Sites Network-St. Petersburg Clinical Research Unit Largo Florida
United States Altea Research Institute Las Vegas Nevada
United States Alivation Research, LLC Lincoln Nebraska
United States Manhattan Behavioral Medicine Manhattan New York
United States Clinical Neuroscience Solutions, Inc. Memphis Tennessee
United States EZY Medical Research Co Miami Florida
United States Premier Clinical Research Institute Miami Florida
United States Behavioral Clinical Research, Inc Miami Lakes Florida
United States North Star Medical Research, LLC Middleburg Heights Ohio
United States Yale Center for Clinical Investigation: Church Street Research Unit (CSRU) New Haven Connecticut
United States Neuro-Behavioral Clinical Research, Inc North Canton Ohio
United States Excell Research Oceanside California
United States IPS Research Company Oklahoma City Oklahoma
United States Paradigm Research Professionals, LLC Oklahoma City Oklahoma
United States NRC Research Institute Orange California
United States Clinical Neuroscience Solutions, Inc. Orlando Florida
United States NoesisPharma LLC Phoenix Arizona
United States Global Medical Institutes, LLC: Princeton Medical Institute Princeton New Jersey
United States Pillar Clinical Research, LLC Richardson Texas
United States CITrials Riverside California
United States Finger Lakes Clinical Research Rochester New York
United States Woodland Research Northwest Rogers Arkansas
United States Clinical Trials of Texas San Antonio Texas
United States Clinical Innovations Inc. Santa Ana California
United States Richmond Behavioral Associates Staten Island New York
United States Collaborative Neuroscience Research, LLC Torrance California
United States Pacific Clinical Research Management Group LLC Upland California
United States Howard University Hospital, Clinical Research Unit Washington District of Columbia
United States Suburban Research Associates West Chester Pennsylvania
United States Grayline Research Center Wichita Falls Texas

Sponsors (1)
Lead Sponsor Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change from Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered, clinical interview where participants report on their symptoms of PTSD on a scale range from 0 to 5, where 0 indicates the symptoms are "absent" and 5 indicates the symptoms are "extreme/incapacitating". Baseline to Week 12
Secondary Mean Change from Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Clinical Global Impression of Severity (CGI-S) is a clinician assessment used to assess the severity of the participants' PTSD on a scale range of 1 to 7, where 1 indicates "normal, not at all ill" and a 7 indicates "among the most extremely ill participants". Baseline to Week 12
Secondary Mean Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Patient Global Impression of Severity (PGI-S) is a patient assessment designed to evaluate severity of PTSD symptoms on a scale from 1 to 5, where 1 indicates "none" and 5 indicates "very severe". Baseline to Week 12
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