A Study of JZP150 in Adults With Posttraumatic Stress Disorder

• ClinicalTrials.gov Identifier: NCT05178316
• Recruitment Status: Completed
• First Posted: January 5, 2022
• Last Update Posted: January 8, 2024
• Sponsor: Jazz Pharmaceuticals
• Information provided by (Responsible Party): Jazz Pharmaceuticals

Tracking Information

• First Submitted Date: December 8, 2021
• First Posted Date: January 5, 2022
• Last Update Posted Date: January 8, 2024
• Actual Study Start Date: December 29, 2021
• Actual Primary Completion Date: December 5, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 16, 2021)

Mean Change from Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score [ Time Frame: Baseline to Week 12 ]

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".

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 16, 2021)

• Mean Change from Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline to Week 12 ]
  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".
• Mean Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) [ Time Frame: Baseline to Week 12 ]
  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".

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of JZP150 in Adults With Posttraumatic Stress Disorder
• 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
• Brief 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).
• Detailed 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).
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Post Traumatic Stress Disorder

Intervention

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

Study Arms

• Experimental: JZP150 0.3 mg
  Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
  Intervention: Drug: JZP150
• Experimental: JZP150 4.0 mg
  Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
  Intervention: Drug: JZP150
• Placebo Comparator: Placebo
  Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2023): 282
• Original Estimated Enrollment (submitted: December 16, 2021): 270
• Actual Study Completion Date: December 5, 2023
• Actual Primary Completion Date: December 5, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05178316
• Other Study ID Numbers: JZP150-201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jazz Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Jazz Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jazz Pharmaceuticals
• Verification Date: January 2024