Chronic Schizophrenia Clinical Trial
Official title:
A Phase IIA, Prospective, Randomized, Double-blind, Multiple-dose Study of NW-3509A in Chronic Schizoprhenia Patients Not Responding to Their Current Anti-psychotic Medication
A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in patients with chronic schizophrenia that are not responding adequately to their current antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose range of 15 to 25 mg, BID in a 1:1 ratio.
This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed
to evaluate the safety, tolerability, and preliminary efficacy of an oral dose range of
NW-3509A of 30 to 50 mg/day (15 to 25 mg, BID) in patients with chronic schizophrenia on a
stable dose of an antipsychotic (aripiprazole or risperidone). A minimum of 90 patients will
be randomized in a 1:1 ratio to receive either NW-3509A (n=45) or placebo (n=45). Dose
increases will be performed only during in-patient setting.
Safety and efficacy assessments will be done on a weekly basis during the randomized
treatment period. The assessment of safety will be based on laboratory tests (biochemistry,
hematology, and urinalysis), 12-lead standard ECG, vital signs, physical examinations,
neurological examinations, C-SSRS, ESRS-A, subjective reporting of any AE by the subject,
objective observation of any AE by the Investigator. Pharmacokinetic samples will be taken
at various time-points. Efficacy assessments will include the PANSS, CGI-C, CGI-S and the
Strauss-Carpenter Level of Functioning (LOF) scale.
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