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

Newron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Schizophrenia

Treatments: Drug: Placebo; Drug: NW-3509A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02624167

NW-3509A/002/II/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

NW-3509A

Active Comparator group

Description:

Patients will start on NW-3509A 15 mg BID and be up-titrated to 20mg, and 25mg BID dependent on tolerability.

Treatment:

Drug: NW-3509A

Placebo

Placebo Comparator group

Description:

Patients will receive matching placebo BID

Treatment:

Drug: Placebo