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.
This is an adaptive, phase IIb/III, multi-center, prospective, randomized, placebo-controlled study, 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, and 8 week double-blind treatment part, and a 52 week Open-Label Extension part. Screening part of the study: The subjects will be evaluated for eligibility during the Screening part of the study. Enrichment run-in part of the study: Subjects who are determined to be eligible will enter the Run-in part of the study. A total of 348 Subjects will be randomized. The randomized subjects will receive 4 weeks of NaBen® or Placebo accordingly. The subjects who have completed 4 weeks of randomized treatment in both groups (NaBen® or Placebo) will be assessed and categorized intoresponders and non-responders, based on 20% or more reduction from baseline in their PANSS total scores as per the evaluations at Visit 2 and Visit 4. Double-Blind treatment part of the study : * Subjects who have successfully completed the Enrichment Run-in part will enter the Double- Blind treatment part of the study per below: NaBen® treated subjects: Subjects will continue receiving NaBen® for another 8 weeks. * Placebo treated subjects: * Placebo Responders: Subjects will continue receiving Placebo for another 8 weeks. * Placebo Non-responders: Subjects will be re-randomized to receive NaBen® or Placebo in a 1:1 ratio for another 8 weeks. Open-Label Extension part of the study: All subjects who have completed the Double-Blind part of the study will continue with the Open-Label Extension part of the study to receive NaBen® for an additional 52 weeks, plus a 2 week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.
Pasadena, California, United States
Positive and Negative Syndrome Scale (PANSS)
Mean change from baseline in PANSS total score
Time frame: 8 weeks after randomized treatment
Positive and Negative Syndrome Scale (PANSS)
Percent change from baseline in PANSS total score
Time frame: 8 weeks after treatment
Positive and Negative Syndrome Scale (PANSS)
Percentage of subjects with 20% or more reduction from baseline in PANSS total score
Time frame: 8 weeks after treatment
PANSS sub-scale scores and Marder PANSS factor scores
Percent change in PANSS sub-scale scores and Marder PANSS factor scores
Time frame: 8 weeks after treatment
Personal and Social Performance (PSP) scale
Percent change of Personal and Social Performance (PSP) scale
Time frame: 8 weeks after treatment
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TREATMENT
Masking
DOUBLE
Enrollment
280