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

March 13, 2017 updated by: Newron Pharmaceuticals SPA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560-029
        • Tirthalli National Institute of Mental Health and Neurosciences
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 040
        • KHM Hospital
    • Tamilnadu
      • Madurai, Tamilnadu, India, 625020
        • Ahana Hospital
  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network.
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NW-3509A
Patients will start on NW-3509A 15 mg BID and be up-titrated to 20mg, and 25mg BID dependent on tolerability.
Drug: NW-3509A
Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A
Placebo Comparator: Placebo
Patients will receive matching placebo BID
Drug: Placebo
Patients will be given oral dose of matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: 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).
27 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Positive and Negative Syndrome Scale (PANSS)
Time Frame: 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
27 days
Assessment of CGI-S (severity) and CGI-C (change)
Time Frame: 27 days; change from baseline
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
Time Frame: 27 days; baseline and end of study
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
Time Frame: 27 days
Blood samples will be collected for PK evaluation at time points
27 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newron Pharmaceuticals SPA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NW-3509A/002/II/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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