A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia

Phase 2

Completed

• Conditions: Chronic Schizophrenia
• Interventions: Drug: Placebo; Drug: NW-3509A

• Registration Number: NCT02624167
• Lead Sponsor: Newron Pharmaceuticals SPA

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.

Study Timeline

• Study First Submitted: 2015-11-20
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive matching placebo BID
NW-3509A	NW-3509A	Patients will start on NW-3509A 15 mg BID and be up-titrated to 20mg, and 25mg BID dependent on tolerability.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measurement of plasma concentration Cmax	27 days	Blood samples will be collected for PK evaluation at time points
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 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 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

Trial Locations

Locations (5)

Collaborative Neuroscience Network.; 🇺🇸 Garden Grove, California, United States

KHM Hospital; 🇮🇳 Chennai, Tamil Nadu, India

Tirthalli National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, India

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Ahana Hospital; 🇮🇳 Madurai, Tamilnadu, India