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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Double-Blind Placebo-Controlled 12-Week Phase 2 Study of Two Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist(EVP-6124)or Placebo in Schizophrenia Subjects on Chronic Stable Atypical Anti-Psychotic Therapy

Conditions
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Schizophrenia, Central Nervous System Diseases, Cognition

Intervention / Treatment
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* Drug: EVP-6124
* Drug: Placebo
* Drug: EVP-6124


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EVP-6124 0.3 mg<br>one 0.3 mg capsule every day for 84 days | Drug: EVP-6124<br>* Arms: 1<br>|
| Active Comparator: EVP-6124 1.0 mg<br>one 1.0 mg capsule every day for 84 days. | Drug: EVP-6124<br>* Arms: 2<br>|
| Placebo Comparator: Placebo<br>Placebo every day for 84 days | Drug: Placebo<br>* Arm: 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Clinical Efficacy |  | 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Central nervous System Diseases, Cognition