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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 318 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05103657
The ClinicalTrials.gov registry entry for NCT05103657 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05103657 reports 0 study locations.
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.
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