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NaBen for Schizophrenia

Phase 2 & 3
Waitlist Available
Led By Robert Findling, MD
Research Sponsored by SyneuRx International (Taiwan) Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up clinical global impression will be assessed at visit 1 (screening), visit 3, 4, 5, and 6
Awards & highlights

Study Summary

This trial will test if NaBen is a safe and effective treatment for schizophrenia in adolescents.

Who is the study for?
Adolescents aged 12-17 with schizophrenia, stable on current antipsychotic meds for at least 8 weeks, in good health without serious medical conditions or drug abuse. They must not be pregnant or nursing and agree to birth control measures.Check my eligibility
What is being tested?
The trial is testing NaBen®, a potential add-on treatment for schizophrenia against a placebo. Adolescents will receive either the real medication or a dummy pill without knowing which one they are taking.See study design
What are the potential side effects?
While specific side effects of NaBen® aren't listed, common ones may include allergic reactions, changes in mood or behavior, dizziness, headaches, and stomach issues. The study aims to assess its safety profile.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~clinical global impression will be assessed at visit 1 (screening), visit 3, 4, 5, and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and clinical global impression will be assessed at visit 1 (screening), visit 3, 4, 5, and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 6 weeks of treatment
Secondary outcome measures
Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score from baseline after 6 weeks of treatment
Percent change from baseline in the PANSS total score after 6 weeks of treatment
Percent change in Positive and Negative Syndrome Scale (PANSS) sub-scales
+3 more
Other outcome measures
Percent change in Children's Depression Rating Scale-Revised (CDRS-R)
Percent change in Children's Global Assessment Scale (CGAS)
Percent change in Clinical Global Impression-Severity (CGI-S)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NaBen®Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
The control treatment is placebo.

Find a Location

Who is running the clinical trial?

SyneuRx International (Taiwan) CorpLead Sponsor
3 Previous Clinical Trials
725 Total Patients Enrolled
2 Trials studying Schizophrenia
635 Patients Enrolled for Schizophrenia
Robert Findling, MDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
5 Previous Clinical Trials
373 Total Patients Enrolled

Media Library

NaBen® Clinical Trial Eligibility Overview. Trial Name: NCT01908192 — Phase 2 & 3
Schizophrenia Research Study Groups: Placebo, NaBen®
Schizophrenia Clinical Trial 2023: NaBen® Highlights & Side Effects. Trial Name: NCT01908192 — Phase 2 & 3
NaBen® 2023 Treatment Timeline for Medical Study. Trial Name: NCT01908192 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any appointments still available for this clinical trial?

"This clinical trial is still looking for participants and was last updated on September 10th, 2021. The study was originally posted on June 1st, 2014."

Answered by AI

To whom does this experiment offer the possibility of inclusion?

"This clinical trial is currently seeking 126 participants aged 12-17 that have been diagnosed with schizophrenia. Key eligibility requirements include: being of male or female gender, meeting specific diagnostic criteria for DSM-IV or -V, having residual symptoms as indicated by a total PANSS score ≥ 60 and SANS score ≥ 40, remaining on the same antipsychotic medication regimen for at least 8 weeks prior to study entry (longer for depot or long-acting antipsychotics), being in good physical health with no clinically remarkable neurological or laboratory findings, having negative results for illicit drugs in a recent urine screening test, understanding and willingness to sign"

Answered by AI

In how many sites is this research being conducted?

"20 different locations are running this clinical trial, these include places like Pacific Institute of Medical Sciences in Bothell, Atlanta Center for Medical Research in Atlanta and Finger Lakes Clinical Research in Rochester."

Answered by AI

Can middle-aged adults participate in this research?

"The current recruitment drive for this clinical trial is seeking patients that are younger than 17 and older than 12 years old."

Answered by AI

How many patients are receiving lenalidomide in this clinical trial?

"In order to move forward, this clinical trial requires 126 willing and eligible patients. The study is being conducted at multiple sites, including Pacific Institute of Medical Sciences in Bothell, Washington and Atlanta Center for Medical Research in Atlanta, Georgia."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®
2014. "Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01908192.
~12 spots leftby Apr 2025
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