Chronic Schizophrenia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGNW-3509A
Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A
DRUGPlacebo
Patients will be given oral dose of matching Placebo
Sponsors
Newron Pharmaceuticals SPA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male/female; if female, must not of childbearing potential 2. 18 to 65 years of age, inclusive; 3. Has a current diagnosis of schizophrenia 4. Has a total score on the PANSS \< 75. 5. Positive symptoms sub-scale score not to exceed 15; score of ≥4 on no more than 2 positive symptoms 6. Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly to moderately severely ill. 7. Is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent). 8. Current symptoms present for at least one month. 9. Patient agrees to be hospitalized for up to 2 days at the start of dosing and at each dose increase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 27 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Positive and Negative Syndrome Scale (PANSS) | 27 days | 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 |
| Assessment of CGI-S (severity) and CGI-C (change) | 27 days; change from baseline | Measure of change from baseline will be done at every assessment |
| Assessment of Strauss-Carpenter Level of Functioning (LOF) scale | 27 days; baseline and end of study | The LOF scale will be used at baseline and end of study, to evaluate the clinical outcome |
| Measurement of plasma concentration Cmax | 27 days | Blood samples will be collected for PK evaluation at time points |
Countries
India, United States
Outcome results
None listed