Clinical trial NCT02624167: A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Schizophrenia
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2015-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 27 days
Secondary outcomes:
measure: Assessment of Positive and Negative Syndrome Scale (PANSS)
timeFrame: 27 days
measure: Assessment of CGI-S (severity) and CGI-C (change)
timeFrame: 27 days; change from baseline
measure: Assessment of Strauss-Carpenter Level of Functioning (LOF) scale
timeFrame: 27 days; baseline and end of study
measure: Measurement of plasma concentration Cmax
timeFrame: 27 days
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network.
state: California
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Chennai
country: India
facility: KHM Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Ahana Hospital
state: Tamilnadu
city: Bangalore
country: India
facility: Tirthalli National Institute of Mental Health and Neurosciences
Study officials:
affiliation: Newron Pharmaceuticals SPA
name: Ravi Anand, MD
role: STUDY_DIRECTOR
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