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Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults

NCT02261519 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-05-24

No results posted yet for this 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.

Conditions

Interventions

DRUG

NaBen®

500 mg twice daily (1000 mg total)

OTHER

Placebo

0 mg twice daily (0 mg total)

Sponsors & Collaborators

  • SyneuRx International (Taiwan) Corp

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2023-11-29
Completion
2023-11-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261519 on ClinicalTrials.gov