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BI 1358894 for Post-Traumatic Stress Disorder

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Did your traumatic event occur more than 3 months ago?
Are you 18 to 65 years of age?
Must not have
Have you taken any stimulants in the past 3 months?
Are you involved in any legal processes related to the traumatic event?
Timeline
Screening 4 weeks
Treatment 8 weeks
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose is to find out whether BI 1358894 improves symptoms.

Eligible Conditions
  • Post-Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 4 weeks
Treatment ~ 8 weeks
Follow Up ~4 weeks
This trial's timeline: 4 weeks for screening, 8 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) total severity score
Secondary outcome measures
Change from baseline on the PTSD Checklist for DSM-5 (PCL-5) total score
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Response defined as ≥30% CAPS-5 reduction from baseline
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Response defined as ≥50% CAPS-5 reduction from baseline

Side effects data

From 2023 Phase 2 trial • 390 Patients • NCT04566601
32%
Headache
9%
Nasopharyngitis
9%
Fatigue
8%
Increased appetite
8%
Dizziness
7%
Influenza
7%
COVID-19
7%
Nausea
6%
Insomnia
6%
Suicidal ideation
5%
Weight increased
4%
Dysmenorrhoea
4%
Oropharyngeal pain
4%
Somnolence
4%
Diarrhoea
3%
Intentional self-injury
3%
Anxiety
2%
Cough
1%
Myocardial infarction
1%
Death
1%
Depression
1%
Suicide attempt
1%
Drug abuse
1%
Oesophageal varices haemorrhage
1%
Abortion spontaneous
1%
Calculus urinary
1%
Jaundice cholestatic
1%
Anaphylactic reaction
1%
Urticaria
1%
Cholelithiasis
1%
Panic attack
1%
Pyrexia
1%
Aggression
1%
Suicidal behaviour
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
BI 1358894 125mg
BI 1358894 5mg
BI 1358894 25mg
BI 1358894 75mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1358894Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1358894
2020
Completed Phase 2
~1160

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,339,974 Total Patients Enrolled

Media Library

BI 1358894 Clinical Trial Eligibility Overview. Trial Name: NCT05103657 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: BI 1358894, Placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: BI 1358894 Highlights & Side Effects. Trial Name: NCT05103657 — Phase 2
BI 1358894 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103657 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05103657 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographical reach of this clinical research?

"27 different patient recruitment centres have been identified for this trial, examples being University of Chicago in Chicago, Mountain Mind in Denver, and Audie L. Murphy VA Hospital in San Antonio."

Answered by AI

Are there any vacancies in the clinical trial available for participants?

"According to the details present on clinicaltrials.gov, this medical experiment is currently seeking participants. It was initiated on December 7th 2021 and has been updated most recently on November 14th 2022."

Answered by AI

Who has the eligibility to become a participant in this clinical trial?

"This study is enrolling 286 individuals aged 18 to 65 who suffer from stress disorders, predominantly PTSD. Other comorbid psychiatric conditions may be present as long as they are not specifically excluded in the criteria."

Answered by AI

What is the upper cap for enrollment in this medical experiment?

"Affirmative. According to the current information on clinicaltrials.gov, this trial is presently enrolling patients who first posted it on December 7th 2021 and updated it last November 14th 2022. The study requires 286 participants from 27 sites in total."

Answered by AI

Has BI 1358894 received authorization from the Food and Drug Administration?

"Due to the lack of evidence supporting its efficacy, BI 1358894 is assessed at a safety level 2. That being said, there are some preliminary data that suggest it may be relatively safe."

Answered by AI

Is this clinical trial open to minor participants?

"To be considered for this trial, participants must fall within the age group of 18 to 65 years old. For individuals outside these parameters there are 46 studies available for those under 18 and 329 for seniors above 65."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Pennsylvania
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Center For Emotional Fitness
Baylor College of Medicine
Relaro Medical Trials, LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
3+

Why did patients apply to this trial?

To get better. I need to take care of. I need help i cant sleep. I need help managing my PTSD.
PatientReceived 2+ prior treatments
Address my medical condition.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening sessions go? What is the payment for this trial? Are there any contraindications for the medication under study? Efficacy if the medicine in trials to date?
PatientReceived 2+ prior treatments
What is going to happen to me if I am accepted into the program? What are the risks involved with this program?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Relaro Medical Trials, LLC: < 24 hours
  2. Baylor College of Medicine: < 48 hours
  3. California Neuroscience Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
2021. "A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05103657.
~95 spots leftby Apr 2025
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