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A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With 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

Summary

This trial tests a new medicine called BI 1358894 to see if it helps people aged 18 to 65 with PTSD. Participants take the medicine regularly for a period of time. The study checks if their symptoms get better and monitors their health.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8
Secondary study objectives
CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8
CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8
Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8

Side effects data

From 2023 Phase 2 trial • 390 Patients • NCT04566601
35%
Headache
12%
Anxiety
12%
Fatigue
12%
Dizziness
10%
Insomnia
10%
Nausea
8%
Diarrhoea
8%
Pyrexia
6%
Suicidal ideation
6%
COVID-19
6%
Nasopharyngitis
6%
Influenza
6%
Disturbance in attention
6%
Oropharyngeal pain
6%
Pharyngitis
6%
Somnolence
4%
Intentional self-injury
4%
Constipation
4%
Dyspepsia
2%
Initial insomnia
2%
Dysmenorrhoea
2%
Suicidal behaviour
2%
Weight increased
2%
Increased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
BI 1358894 5mg
BI 1358894 125mg
Placebo
BI 1358894 75mg
BI 1358894 25mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1358894 125 mgExperimental 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
~1480

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
2,554 Previous Clinical Trials
15,896,977 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 125 mg, 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
~79 spots leftby Dec 2025
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