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NCT04624243 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 499
- Enrollment target
NCT04624243 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 499 participants.
The verdict
NCT04624243, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 499 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy and safety of elpipodect at a range of doses (8 mg, 16 mg, and 24 mg once daily \[QD\]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses were the following: (1) that elpipodect 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, and (2) that elpipodect 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score. With Amendment 4, enrollment was changed to approximately 500 participants with removal of the elpipodect 8 mg treatment arm. Participants enrolled before Amendment 4 who were assigned to elpipodect 8 mg QD remained on that dose regimen per protocol.
Interventions
- DRUG Risperidone
- DRUG Elpipodect
- DRUG Placebo to MK-8189
- DRUG Placebo to risperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2024-06-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04624243
The ClinicalTrials.gov registry entry for NCT04624243 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 499 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.
NCT04624243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04624243 about?
NCT04624243 is a clinical study titled "Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)". The purpose of this study was to evaluate the efficacy and safety of elpipodect at a range of doses (8 mg, 16 mg, and 24 mg once daily \[QD\]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) crite...
What is the current status of trial NCT04624243?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 499 participants. The study started on 2020-12-15. Estimated completion is 2024-06-21.
What interventions are being tested in trial NCT04624243?
The interventions under investigation include: Risperidone (DRUG), Elpipodect (DRUG), Placebo to MK-8189 (DRUG), Placebo to risperidone (DRUG).
Who is sponsoring clinical trial NCT04624243?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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