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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: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04624243 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 499 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (275% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranges from 30 (lowest total score) to 210 (highest total s
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 |
What the finished NCT04624243 record still lists
NCT04624243 is an interventional study that assigns participants to a tested intervention. The registered 499 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 (275% higher).
The record links to 0 conditions, and to 4 interventions - of which Risperidone is the first listed.
NCT04624243 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04624243's enrollment target sits among peer trials
499 74th of 2000 higher than 1,927 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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