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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: Clinical Trial Phase 2 study, sponsored by SyneuRx International (Taiwan).
NCT02261519 is a Phase 2 study that was terminated before completion, run by SyneuRx International (Taiwan). The registered enrollment target is 280 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean change from baseline in PANSS total score
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 |
Why NCT02261519 stopped before completion
NCT02261519 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02261519 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02261519's enrollment target sits among peer trials
280 196th of 2000 higher than 1,800 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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