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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NW-3509A | Active Comparator | Patients will start on NW-3509A 15 mg BID and be up-titrated to 20mg, and 25mg BID dependent on tolerability. |
|
| Placebo | Placebo Comparator | Patients will receive matching placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NW-3509A | Drug | Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 27 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 27 days |
| Assessment of CGI-S (severity) and CGI-C (change) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Anand, MD | Newron Pharmaceuticals SPA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network. | Garden Grove | California | 92845 | United States | ||
| Hassman Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 12496955 | Background | Casey DE, Daniel DG, Wassef AA, Tracy KA, Wozniak P, Sommerville KW. Effect of divalproex combined with olanzapine or risperidone in patients with an acute exacerbation of schizophrenia. Neuropsychopharmacology. 2003 Jan;28(1):182-92. doi: 10.1038/sj.npp.1300023. |
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| Placebo |
| Drug |
Patients will be given oral dose of matching Placebo |
|
Measure of change from baseline will be done at every assessment |
| 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 | 27 days; baseline and end of study |
| Measurement of plasma concentration Cmax | Blood samples will be collected for PK evaluation at time points | 27 days |
| Berlin |
| New Jersey |
| 08009 |
| United States |
| KHM Hospital | Chennai | Tamil Nadu | 600 040 | India |
| Ahana Hospital | Madurai | Tamil Nadu | 625020 | India |
| Tirthalli National Institute of Mental Health and Neurosciences | Bangalore | 560-029 | India |
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| Background | Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, May 28, 2009 (v4.03 June 14, 2010), U.S. Department of Health and Human Services. |
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