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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Schizophrenia

In brief

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.

Key facts

Study ID

NCT02624167

Run by

Newron Pharmaceuticals SPA

People needed

90

Starts

2015-12-01

Expected to finish

2017-01-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male/female; if female, must not of childbearing potential
• 18 to 65 years of age, inclusive;
• Has a current diagnosis of schizophrenia
• Has a total score on the PANSS < 75.
• Positive symptoms sub-scale score not to exceed 15; score of ≥4 on no more than 2 positive symptoms
• Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly to moderately severely ill.
• 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).
• Current symptoms present for at least one month.
• Patient agrees to be hospitalized for up to 2 days at the start of dosing and at each dose increase

Where it is running

• Collaborative Neuroscience Network. — Garden Grove, California, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• KHM Hospital — Chennai, Tamil Nadu, India
• Ahana Hospital — Madurai, Tamil Nadu, India
• Tirthalli National Institute of Mental Health and Neurosciences — Bangalore, India

Full record on ClinicalTrials.gov

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