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NCT03397134 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia
A Phase 3 study of Negative Symptoms of Schizophrenia, sponsored by Minerva Neurosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
- 20
- Study locations
NCT03397134 is a Phase 3 study of Negative Symptoms of Schizophrenia that has completed, run by Minerva Neurosciences. The registered enrollment target is 515 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT03397134, a Phase 3 study of Negative Symptoms of Schizophrenia, has completed, sponsored by Minerva Neurosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
- 20
- Study locations
Study Summary
MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12 weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Roluperidone 32 mg
- DRUG Roluperidone 64 mg
Study Locations (20)
Other
- "Mental Health Center Prof. Dr. Ivan Temkov - Burgas" EOOD Department For Treatment of Emergency Psychiatry Conditions - Burgas
- State Psychiatry Hospital - Lovech - Lovech
- State Psychiatry Hospital "Sveti Ivan Rilski" Department of General Psychiatry for adults "closed type" - males; Department of General Psychiatry for adults "closed type" - females - Novi Iskar
- 'Mental Health Center Plovdiv"-EOOD Department for treatment of acute female/male psychoses with endogenous, exogenous, organic psychotic disturbances of the personality - Plovdiv
- Multiprofile Hospital for Active Treatment - Targovishte" AD Department of Psychiatry - Targovishte
- "Mental Health Center - Vratsa" General Psychiatric Department - Vratsa
California
- ProScience Research Group - Culver City
- Collaborative Neuroscience Network, LLC. - Garden Grove
- Synergy Clinical Center - National City
- Collaborative Neuroscience Network, LLC. - Torrance
Florida
- Behavioral Clinical Research, Inc - North Miami
- Research Centers of America, LLC - Oakland Park
Texas
- InSite Clinical Research LLC - DeSoto
- Pillar Clinical Research LLC - Richardson
Arkansas
- Woodland Research Northwest - Rogers
Georgia
- Atlanta Center for Medical Research - Atlanta
Illinois
- Uptown Research Institute LLC - Chicago
New Jersey
- Hassman Research Institute, LLC. - Berlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2021-02-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03397134
The ClinicalTrials.gov registry entry for NCT03397134 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 515 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minerva Neurosciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Negative Symptoms of Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo Oral Tablet is the first listed.
NCT03397134 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03397134 about?
NCT03397134 is a clinical study titled "Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia". MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in...
What is the current status of trial NCT03397134?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2017-12-15. Estimated completion is 2021-02-15.
What conditions does trial NCT03397134 study?
This clinical trial studies the following conditions: Negative Symptoms of Schizophrenia.
What interventions are being tested in trial NCT03397134?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Roluperidone 32 mg (DRUG), Roluperidone 64 mg (DRUG).
Who is sponsoring clinical trial NCT03397134?
This trial is sponsored by Minerva Neurosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03397134 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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