Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia; Central Nervous System Diseases; Cognition
• Interventions: Drug: EVP-6124; Drug: Placebo

• Registration Number: NCT00968851
• Lead Sponsor: FORUM Pharmaceuticals Inc

Brief Summary

This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.

Detailed Description

This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication.

Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.

Study Timeline

• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2009-12
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Disposition First Submitted: 2012-02-23
• Status Verified: 2012-03
• Disposition First Submitted QC: 2012-03-02
• Disposition First Posted: 2012-03-06
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)
• Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
• Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
• A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
• A minimal level of depression; Calgary Depression Scale total score ≤10
• Must have a general health status acceptable for participation in a 12-week clinical trial
• Fluency (oral and written) in the language in which the standardized tests will be administered
• If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing

Exclusion Criteria

General

• Insufficiently controlled diabetes mellitus in the judgment of the investigator
• Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
• Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
• Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVP-6124 1.0 mg	EVP-6124	one 1.0 mg capsule every day for 84 days.
Placebo	Placebo	Placebo every day for 84 days
EVP-6124 0.3 mg	EVP-6124	one 0.3 mg capsule every day for 84 days

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function.	84 days

Secondary Outcome Measures

Name	Time	Method
Assessment of Clinical Efficacy	84 days

Trial Locations

Locations (17)

Intergrated Medical and Behavioral Associates; 🇺🇸 Glendale, California, United States

Excell Research; 🇺🇸 Oceanside, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Affiliated Research Institute; 🇺🇸 San Diego, California, United States

Schuster Medical Research Institute; 🇺🇸 Sherman Oaks, California, United States

Scientific Clinical Research, Inc.; 🇺🇸 North Miami, Florida, United States

Uptown Research Institute; 🇺🇸 Chicago, Illinois, United States

Alexian Brothers Behavioral Health; 🇺🇸 Hoffman Estates, Illinois, United States

CBH Health, LLC; 🇺🇸 Rockville, Maryland, United States

CRI Worldwide; 🇺🇸 Willingboro, New Jersey, United States

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