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NCT05103657 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 318
- Enrollment target
NCT05103657: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT05103657 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 318 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (139% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05103657, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 318 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DRUG Placebo
- DRUG BI 1358894
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2023-11-20 |
| Phase | Phase 2 |
What the finished NCT05103657 record still lists
NCT05103657 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (139% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05103657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05103657 about?
NCT05103657 is a clinical study titled "A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder". 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. Part...
What is the current status of trial NCT05103657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 318 participants. The study started on 2021-12-07. Estimated completion is 2023-11-20.
What interventions are being tested in trial NCT05103657?
The interventions under investigation include: Placebo (DRUG), BI 1358894 (DRUG).
Who is sponsoring clinical trial NCT05103657?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05103657's enrollment target sits among peer trials
318 153rd of 2000 higher than 1,846 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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