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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JZP150 0.3 mg | Experimental | Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks. |
|
| JZP150 4.0 mg | Experimental | Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks. |
|
| Placebo | Placebo Comparator | Participants who will be randomized to receive placebo orally once daily for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP150 | Drug | Oral administration of JZP150 once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. The CAPS-5 total score ranges between 0 and 80. Higher scores indicate more severe PTSD symptoms. Change in CAPS-5 total score is being reported, where negative mean scores indicate an improvement in clinical outcome. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". Change in CGI-S is being reported with negative mean values indicating an improvement in clinical outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NoesisPharma LLC | Phoenix | Arizona | 85016 | United States | ||
| Sanro Clinical Research Group, LLC |
In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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A total of 282 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment. Of those 282 participants, 277 received at least 1 dose of study intervention. Five participants did not receive any treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | JZP150 0.3 mg | Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks. |
| FG001 | JZP150 4.0 mg | Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2022 | Dec 3, 2024 |
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| Placebo | Drug | Oral administration of placebo once daily in the morning |
|
| Baseline to Week 12 |
| 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". Change in PGI-S is being reported with negative mean values indicating an improvement in clinical outcome. | Baseline to Week 12 |
| Bryant |
| Arkansas |
| 72022 |
| United States |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | United States |
| Clinical Innovations Inc. | Bellflower | California | 90706 | United States |
| Southern California Research, LLC | Beverly Hills | California | 90210 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| CITrials | Riverside | California | 92506 | United States |
| Clinical Innovations Inc. | Santa Ana | California | 90705 | United States |
| Collaborative Neuroscience Research, LLC | Torrance | California | 90504 | United States |
| Pacific Clinical Research Management Group LLC | Upland | California | 91786 | United States |
| MCB Clinical Research Center | Colorado Springs | Colorado | 80910 | United States |
| CT Clinical Research | Cromwell | Connecticut | 06416 | United States |
| Yale Center for Clinical Investigation: Church Street Research Unit (CSRU) | New Haven | Connecticut | 06519 | United States |
| Howard University Hospital, Clinical Research Unit | Washington D.C. | District of Columbia | 20060 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Accel Research Sites -Lakeland Clinical Research Unit | Lakeland | Florida | 33803 | United States |
| Accel Research Sites Network-St. Petersburg Clinical Research Unit | Largo | Florida | 33777 | United States |
| Premier Clinical Research Institute | Miami | Florida | 33122 | United States |
| EZY Medical Research Co | Miami | Florida | 33175 | United States |
| Behavioral Clinical Research, Inc | Miami Lakes | Florida | 33016 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Advanced Discovery Research | Atlanta | Georgia | 30318 | United States |
| CenExel iResearch | Decatur | Georgia | 30030 | United States |
| American Medical Research, Inc | Chicago | Illinois | 60612 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Clinical Trial | Boston | Massachusetts | 02131 | United States |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Global Medical Institutes, LLC: Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| SPRI Clinical Trials | Brooklyn | New York | 11235 | United States |
| Manhattan Behavioral Medicine | Manhattan | New York | 10036 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Neuro-Behavioral Clinical Research, Inc | North Canton | Ohio | 44720 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | United States |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73118 | United States |
| Suburban Research Associates | West Chester | Pennsylvania | 19380 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Dell Medical School Universityof Texas at Austin | Austin | Texas | 78712 | United States |
| Austin Clinical Trial Partners | Austin | Texas | 78737 | United States |
| Houston Clinical Trials | Bellaire | Texas | 77401 | United States |
| Relaro Medical Trials, LLC | Dallas | Texas | 75243 | United States |
| Northpointe Psychiatry | Flower Mound | Texas | 75028 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Grayline Research Center | Wichita Falls | Texas | 76309 | United States |
| Eastside Therapeutic Resource | Everett | Washington | 98201 | United States |
| FG002 | Placebo | Participants who were randomized to placebo orally once daily for up to 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
|
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Baseline characteristics were assessed in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | JZP150 0.3 mg | Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks. |
| BG001 | JZP150 4.0 mg | Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks. |
| BG002 | Placebo | Participants who were randomized to placebo orally once daily for up to 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Age Group 1 was assessed in the Safety Analysis Set. | Count of Participants | Participants |
| |||||||||||||||
| Age, Customized | Age Group 2 was assessed in the Safety Analysis Set. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. The CAPS-5 total score ranges between 0 and 80. Higher scores indicate more severe PTSD symptoms. Change in CAPS-5 total score is being reported, where negative mean scores indicate an improvement in clinical outcome. | CAPS-5 total symptom severity score was assessed in participants with available data in the Full Analysis Set 1. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
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| 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". Change in CGI-S is being reported with negative mean values indicating an improvement in clinical outcome. | CGI-S was assessed in participants with available data in the Full Analysis Set 1 (defined as | Posted | Mean | Standard Deviation | score on a scale | 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". Change in PGI-S is being reported with negative mean values indicating an improvement in clinical outcome. | PGI-S was assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
|
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Adverse events were collected from baseline to Week 12.
Due to the receipt of the incorrect intervention, 1 participant who was randomized to the JZP150 0.3 mg arm actually received placebo as their first dose, and thus was analyzed in the JZP150 0.3 mg arm for the Full Analysis Set 2 and in the placebo arm for the Safety Analysis Set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JZP150 0.3 mg | Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks. | 0 | 54 | 1 | 54 | 20 | 54 |
| EG001 | JZP150 4.0 mg | Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks. | 0 | 113 | 2 | 113 | 30 | 113 |
| EG002 | Placebo | Participants who were randomized to placebo orally once daily for up to 12 weeks. | 0 | 110 | 1 | 110 | 24 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA26 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA26 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA26 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA26 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA26 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA26 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA26 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA26 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA26 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA26 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA26 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Jazz Pharmaceuticals | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2023 | Dec 3, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| >65 years |
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| >45 years |
|
| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Declined to state |
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| Multiple |
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| =0.6832 |
| Least squares mean difference |
| -0.74 |
| Standard Error of the Mean |
| 1.817 |
| 2-Sided |
| 95 |
| -4.32 |
| 2.84 |
| Superiority |
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| Participants |
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| Participants |
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