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NCT03055338 · ClinicalTrials.gov registry record · Phase 2
An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
NCT03055338 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 224 participants.
The verdict
NCT03055338, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
Study Summary
This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect compared with placebo, using Risperidone as an active control. The participants will be adult subjects experiencing an acute episode of schizophrenia, according to the criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each participant. The study will consist of a Screening/tapering period (up to one week long), a 4-week treatment period, and a 14-day follow-up period. The primary objective will be to assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during treatment and post-treatment follow-up. The secondary objective will be to assess the severity of schizophrenia at 4 weeks. The primary hypothesis is that elpipodect is superior to placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of treatment.
Interventions
- DRUG Risperidone
- DRUG Elpipodect
- DRUG Placebo matching MK-8189
- DRUG Placebo matching risperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2018-01-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03055338
The ClinicalTrials.gov registry entry for NCT03055338 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Risperidone is the first listed.
NCT03055338 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03055338 about?
NCT03055338 is a clinical study titled "An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)". This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect compared with placebo, using Risperidone as an active control. The participants will be adult subjects experiencing an acute episode of schizophrenia, according to the criteria specified in th...
What is the current status of trial NCT03055338?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2017-03-08. Estimated completion is 2018-01-09.
What interventions are being tested in trial NCT03055338?
The interventions under investigation include: Risperidone (DRUG), Elpipodect (DRUG), Placebo matching MK-8189 (DRUG), Placebo matching risperidone (DRUG).
Who is sponsoring clinical trial NCT03055338?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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