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NCT03978832 · ClinicalTrials.gov registry record · Phase 4
Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone
A Phase 4 study of Schizophrenia, sponsored by Indivior.
- Completed
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT03978832: Completed Phase 4 study of Schizophrenia, sponsored by Indivior.
NCT03978832 is a Phase 4 study of Schizophrenia that has completed, run by Indivior. The registered enrollment target is 69 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03978832, a Phase 4 study of Schizophrenia, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates PERSERIS at a higher dose than what has been administered in previous clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose
Primary Outcome
Cavg,ss for risperidone and total active moiety after oral and SC administration
Conditions Studied
Interventions
- DRUG Risperidone
- DRUG PERSERIS
Study Locations (1)
California
- Collaborative Neuroscience Network - Garden Grove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2020-05-12 |
| Phase | Phase 4 |
What the finished NCT03978832 record still lists
NCT03978832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Risperidone is the first listed.
NCT03978832 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03978832 about?
NCT03978832 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone". This study evaluates PERSERIS at a higher dose than what has been administered in previous clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose
What is the current status of trial NCT03978832?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2019-06-28. Estimated completion is 2020-05-12.
What conditions does trial NCT03978832 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT03978832?
The interventions under investigation include: Risperidone (DRUG), PERSERIS (DRUG).
Who is sponsoring clinical trial NCT03978832?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03978832 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03978832's enrollment target sits among peer trials
69 178th of 315 higher than 137 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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.
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