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)

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

Clinical Site 1; 🇷🇸 Belgrade, Serbia

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

Clinical Site 2; 🇷🇸 Belgrade, Serbia

Clinical Site 3; 🇷🇸 Belgrade, Serbia

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

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

FutureSearch Clinical Trials, L.P.; 🇺🇸 Austin, Texas, United States

InSite Clinical Research; 🇺🇸 DeSoto, Texas, United States

Excell Research; 🇺🇸 Oceanside, California, United States

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

Carolina Clinical Trials, Inc.; 🇺🇸 Charleston, South Carolina, United States

Vanderbilt Psychiatric Hospital; 🇺🇸 Nashville, Tennessee, United States

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

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

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

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