An Adaptive, Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy OF NaBen® , A D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for Schizophrenia in Adolescents

Who is this study for? Patients with Schizophrenia
What treatments are being studied? NaBen®
Status: Terminated
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Male or female subjects who are between 12 and 17 years of age inclusive

• Physician confirmed DSM-IV or -V diagnosis of schizophrenia based on MINI International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies for Children and Adolescents, version 6.0 (MINI-KID, Version 6.0)

• Are clinically stable with residual symptoms, defined as a total score of ≥ 60 of PANSS and a score of ≥ 40 for SANS

• An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to randomization into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole (Maintena®) and Paliperidone (Xeplion®); six (6) months for Olanzapine pamoate monohydrate (Zypadhera®); and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics)

• In good general physical health and all physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) are clinically unremarkable per the investigator

• Subject has a negative urine illicit drug screening test

• Subject understands and is willing to sign the Informed Assent Form (IAF) prior to study entry and agrees to be available for all the study visits

• The subject's guardian understands and is willing to sign the Informed Consent Form (ICF) prior to study entry and agrees to be available for all the study visits

• Must not be a danger to self or others and must have family support available to be maintained as outpatients

Locations
United States
Alabama
Harmonex Neuroscience Research
Dothan
California
CiTrials
Bellflower
Renew Behavioral Health, Inc.
Long Beach
CiTrials
Riverside
Connecticut
Institute of Living/Hartford Hospital
Hartford
Washington, D.c.
Children's National Health System
Washington
Florida
Premier Clinical Research Institute
Miami
Medical Research Group of Central Florida
Orange City
Georgia
Atlanta Center for Medical Research
Atlanta
Massachusetts
University of Massachusetts Medical School - Psychiatry Department
Worcester
Maryland
John Hopkins University - Hugo W Moser Research Institute at Kennedy Krieger Inc.
Baltimore
Michigan
Michigan Clinical Research Institute
Ann Arbor
Minnesota
University of Minnesota Medical Center - Department of Psychiatry
Minneapolis
Mississippi
Precise Research Centers
Flowood
New York
Finger Lakes Clinical Research
Rochester
Ohio
University of Cincinnati - Dept. of Psychiatry and Behavioral Neuroscience
Cincinnati
University Hospitals Case Medical Center
Cleveland
Texas
Focus and Balance LLC
San Antonio
Washington
Pacific Institute of Medical Sciences
Bothell
Zain Research, LLC
Richland
Other Locations
Taiwan
Chang Gung Memorial Hospital (Linkou)
New Taipei City
Chang Gung Memorial Hospital (Taipei)
Taipei
Veteran General Hospital Taipei
Taipei
Time Frame
Start Date: 2014-06
Completion Date: 2023-10-26
Participants
Target number of participants: 60
Treatments
Experimental: NaBen®
NaBen® is a white oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.
Placebo_comparator: Placebo
The control treatment is placebo.
Related Therapeutic Areas
Sponsors
Leads: SyneuRx International (Taiwan) Corp

This content was sourced from clinicaltrials.gov