A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder

NCT05103657 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1402-00302021-003154-23
• Study Type: interventional
• Target: 318
• Locations: 8 countries
• Sites: 61

Brief Summary

This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8

  CAPS-5 is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Least Squares (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.

  The MMRM model is a longitudinal analysis and it incorporated CAPS-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported.

Secondary Outcomes (3)

• CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8

  At baseline and at 8 weeks after start of treatment.

• CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8

  At baseline and at 8 weeks after start of treatment.

• Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8

  The MMRM model is a longitudinal analysis and it incorporated PCL-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported.

Study Arms (2)

BI 1358894 125 mg

EXPERIMENTAL

Drug: BI 1358894

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1358894 DRUG

BI 1358894

BI 1358894 125 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of Post-Traumatic Stress Disorder (PTSD) corresponding to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
• Time since index event according to Life Events Checklist / Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Criterion A at least 3 months before screening visit

You may not qualify if:

• A total severity score of ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5) at the screening visit
• Moderate to severe PTSD confirmed by CAPS-5 range ≥ 30 confirmed at screening visit
• Male or female patients, 18 to 65 years of age, both inclusively at the time of informed consent
• Women who are of child-bearing potential (WOCBP) must be able and willing to use two methods of contraception, as confirmed by the investigator, which include one highly effective method of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier method
• Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Corresponding to DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder, brief psychotic disorder or any other psychotic disorder as well as Major Depressive Disorder (MDD) with psychotic features as assessed by the Mini-International Neuropsychiatric Interview (MINI) at the time of screening
• Any psychiatric or non-psychiatric medical condition likely to negatively impact trial participation as per the judgement of the investigator
• Acute stress disorder or significant traumatic event within 3 months prior to the screening visit
• Severe traumatic brain injury (life-time) or moderate traumatic brain injury within the last 2 years prior to screening visit or 3 months for mild traumatic brain injury, based on the Ohio State University Traumatic Brain Injury (TBI) Identification Method Short Form. Or history of traumatic brain injury that would impact ability to complete trial assessments or procedures according to investigator.
• Current treatment with trauma focused therapy (i.e. Cognitive Processing Therapy (CPT), Prolonged Exposure Therapy (PE), Eye Movement Desensitization and Reprocessing (EMDR)). A psychotherapy in type, intensity and/or frequency other than trauma focused therapy is allowed if stable within the last 8 weeks prior to screening and not anticipated to change during the entire course of the trial. Long-term psychotherapy is permitted as long as patients are not in an exposure phase during the trial.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (61)

Woodland International Research Group, Inc.

Little Rock, Arkansas, 72211, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

ASCLEPES Research Centers, P.C. dba Alliance Research

Long Beach, California, 90807, United States

Location

CalNeuro Research Group Inc.

Los Angeles, California, 90025, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Artemis Institute for Clinical Research, LLC

San Diego, California, 92103, United States

Location

Clinical Innovations Inc.

Santa Ana, California, 92705, United States

Location

California Neuroscience Research

Sherman Oaks, California, 91403, United States

Location

Collaborative Neuroscience Research, LLC

Torrance, California, 90504, United States

Location

Mountain Mind. LLC

Denver, Colorado, 80202, United States

Location

CNS Clinical Research - Coral Springs

Coral Springs, Florida, 33067, United States

Location

Innovative Clinical Research

Lauderhill, Florida, 33319, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Elixia PHC, LLC

St. Petersburg, Florida, 33713, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30022, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

American Medical Research

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Pharmasite Research, Incorporated

Baltimore, Maryland, 21208, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Sisu BHR, LLC

Springfield, Massachusetts, 01103, United States

Location

NeuroBehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Center For Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Insight Clinical Trials

Beachwood, Ohio, 44122, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Relaro Medical Trials, LLC

Dallas, Texas, 75243, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

Audie L. Murphy VA Hospital

San Antonio, Texas, 78229, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Salem VA Medical Center

Salem, Virginia, 24153, United States

Location

Clincal Hospital Centre Rijeka

Rijeka, 51 000, Croatia

Location

Polyclinic Neuron

Zagreb, 10000, Croatia

Location

Solmed Polyclinic

Zagreb, 10000, Croatia

Location

Psychiatric Hospital 'Sveti Ivan'

Zagreb, 10090, Croatia

Location

University Psychiatric Hospital Vrapce

Zagreb, 10090, Croatia

Location

Eira Medical Centre

Helsinki, 00150, Finland

Location

Oulu Mentalcare Oy

Oulu, 90100, Finland

Location

Mehiläinen Tampere

Tampere, FI-33210, Finland

Location

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

Location

Zentralinstitut für seelische Gesundheit

Mannheim, 68159, Germany

Location

Klinikum der Universität München - Campus Innenstadt

München, 80336, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

The Chaim Sheba Medical Center Tel HaShomer

Tel Litwinsky, 52621, Israel

Location

Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

Culiacán, 80230, Mexico

Location

Hospital Aranda de la Parra

León, 37000, Mexico

Location

CIT-Neuropsique S.C

Monterrey, 64610, Mexico

Location

BIND Investigaciones S.C.

San Luis Potosí City, 78213, Mexico

Location

MlynowaMed

Bialystok, 15-404, Poland

Location

In-Vivo Sp. Z o.o.

Bydgoszcz, 85-048, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

Location

Psykiatri Södra Stockholm

Enskede, 122 31, Sweden

Location

Psykiatri Affektiva sjukdomar

Gothenburg, 416 50, Sweden

Location

Psykiatri Sydväst Stockholm

Huddinge/Stockholm, 141 86, Sweden

Location

Akademiska sjukhuset

Uppsala, 751 85, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

TRPC inhibitor BI 1358894

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: December 7, 2021
• Primary Completion: October 12, 2023
• Study Completion: November 20, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

DE (4); US (37); PL (3); IL (1); FI (3); CR (5); SE (4); ME (4)