NCT00968851

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: FORUM Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Central Nervous System Diseases
• Cognition

Interventions

Type	Name	Description
DRUG	EVP-6124	Arms: 1
DRUG	Placebo	Arm: 3
DRUG	EVP-6124	Arms: 2

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2009-08-31
• Last updated: 2014-04-25

Locations

31 sites across 4 countries: United States, Russia, Serbia, Ukraine