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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newron; Newron Pharmaceuticals SPA

Criteria

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