An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
NCT03094429
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
Summary
This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Refractory Schizophrenia
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2/3
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- SyneuRx International (Taiwan) Corp
- Last updated on ClinicalTrials.gov
- September 13, 2021
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- For additional information regarding investigative sites for this trial, contact SyneuRx International Corp. · Pasadena, CA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.