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

Chronic Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624167
• Other study ID #: NW-3509A/002/II/2015
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2015
• Last updated: March 13, 2017
• Start date: December 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Newron
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Schizophrenia

Intervention

Drug:
• NW-3509A
Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A
• Placebo
Patients will be given oral dose of matching Placebo

Locations

Country	Name	City	State
India	Tirthalli National Institute of Mental Health and Neurosciences	Bangalore
India	KHM Hospital	Chennai	Tamil Nadu
India	Ahana Hospital	Madurai	Tamilnadu
United States	Hassman Research Institute	Berlin	New Jersey
United States	Collaborative Neuroscience Network.	Garden Grove	California

Sponsors (1)

Lead Sponsor	Collaborator
Newron

Countries where clinical trial is conducted

United States,  India, 

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Assessment of CGI-S (severity) and CGI-C (change)	Measure of change from baseline will be done at every assessment	27 days; change from baseline
Secondary	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
Secondary	Measurement of plasma concentration Cmax	Blood samples will be collected for PK evaluation at time points	27 days