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NCT02261519 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults
A Phase 2 study, sponsored by SyneuRx International (Taiwan).
- Terminated
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
NCT02261519 is a Phase 2 study that was terminated before completion, run by SyneuRx International (Taiwan). The registered enrollment target is 280 participants.
The verdict
NCT02261519, a Phase 2 study, was terminated before completion, sponsored by SyneuRx International (Taiwan).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
Study Summary
The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a multi-center, prospective, randomized, placebo-controlled, in which adult subjects with schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a 4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension part.
Interventions
- OTHER Placebo
- DRUG NaBen®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2023-11-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02261519
The ClinicalTrials.gov registry entry for NCT02261519 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SyneuRx International (Taiwan), which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02261519 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02261519 about?
NCT02261519 is a clinical study titled "Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults". The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a multi-center, prospective, r...
What is the current status of trial NCT02261519?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2017-03-29. Estimated completion is 2023-11-29.
What interventions are being tested in trial NCT02261519?
The interventions under investigation include: Placebo (OTHER), NaBen® (DRUG).
Who is sponsoring clinical trial NCT02261519?
This trial is sponsored by SyneuRx International (Taiwan), which has 3 total clinical trials registered on ClinicalTrials.gov.
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