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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Collaborative Neuroscience Network.
Garden Grove, California, United States
Hassman Research Institute
Berlin, New Jersey, United States
KHM Hospital
Chennai, Tamil Nadu, India
Ahana Hospital
Madurai, Tamil Nadu, India
To evaluate the safety and tolerability of NW-3509A in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).
To evaluate the safety and tolerability of NW-3509A given as an oral dose range of 30 to 50 mg/day (15 to 25 mg, BID) in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).
Time frame: 27 days
Assessment of Positive and Negative Syndrome Scale (PANSS)
Assessment of the PANSS - a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control, will be carried out at every visit
Time frame: 27 days
Assessment of CGI-S (severity) and CGI-C (change)
Measure of change from baseline will be done at every assessment
Time frame: 27 days; change from baseline
Assessment of Strauss-Carpenter Level of Functioning (LOF) scale
The LOF scale will be used at baseline and end of study, to evaluate the clinical outcome
Time frame: 27 days; baseline and end of study
Measurement of plasma concentration Cmax
Blood samples will be collected for PK evaluation at time points
Time frame: 27 days
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Tirthalli National Institute of Mental Health and Neurosciences
Bangalore, India