NCT05103657

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

A Phase II, 8-week-treatment, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy, Tolerability and Safety of Orally Administered BI 1358894 in Patients With Post-Traumatic Stress Disorder (PTSD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	BI 1358894	BI 1358894
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-12-07
• Primary completion: 2023-10-12
• Completion: 2023-11-20
• First posted: 2021-11-02
• Last updated: 2024-11-07
• Results posted: 2024-11-07

Locations

61 sites across 8 countries: United States, Croatia, Finland, Germany, Israel, Mexico, Poland, Sweden

Regulatory

• FDA-regulated drug study