Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03870880 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension
A Phase 3 study, sponsored by Rovi Pharmaceuticals Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 215
- Enrollment target
NCT03870880 is a Phase 3 study that has completed, run by Rovi Pharmaceuticals Laboratories. The registered enrollment target is 215 participants.
The verdict
NCT03870880, a Phase 3 study, has completed, sponsored by Rovi Pharmaceuticals Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 215 participants
- Enrollment target
Study Summary
This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.
Interventions
- DRUG Risperidone ISM 75 mg
- DRUG Risperidone ISM 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2017-08-25 |
| Est. Completion | 2020-01-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03870880
The ClinicalTrials.gov registry entry for NCT03870880 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rovi Pharmaceuticals Laboratories, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Risperidone ISM 75 mg is the first listed.
NCT03870880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03870880 about?
NCT03870880 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension". This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension se...
What is the current status of trial NCT03870880?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 215 participants. The study started on 2017-08-25. Estimated completion is 2020-01-08.
What interventions are being tested in trial NCT03870880?
The interventions under investigation include: Risperidone ISM 75 mg (DRUG), Risperidone ISM 100 mg (DRUG).
Who is sponsoring clinical trial NCT03870880?
This trial is sponsored by Rovi Pharmaceuticals Laboratories, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.