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Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®

NCT01908192 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-09

No results posted yet for this study

Summary

The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.

Conditions

Interventions

DRUG

NaBen®

The Study Treatment is NaBen®, which will look, and will be packaged and maintained exactly the same way as the Control Treatment (Placebo).

DRUG

Placebo

The ingredients in the Control Treatment are exactly the same as in the Study Treatment, except without the primary active ingredient.

Sponsors & Collaborators

  • SyneuRx International (Taiwan) Corp

    lead INDUSTRY

Principal Investigators

  • Robert Findling, MD · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2023-10-26
Completion
2023-10-26

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT01908192 on ClinicalTrials.gov