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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: Completed Phase 3 study, sponsored by Rovi Pharmaceuticals Laboratories.
NCT03870880 is a Phase 3 study that has completed, run by Rovi Pharmaceuticals Laboratories. The registered enrollment target is 215 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicates improvements in sympto
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 |
What the finished NCT03870880 record still lists
NCT03870880 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Risperidone ISM 75 mg is the first listed.
NCT03870880 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03870880's enrollment target sits among peer trials
215 1334th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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