Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
|Schizophrenia Central Nervous System Diseases Cognition||Drug: EVP-6124 Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 84 days ]
- Assessment of Clinical Efficacy [ Time Frame: 84 days ]
|Study Start Date:||December 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: EVP-6124 0.3 mg
one 0.3 mg capsule every day for 84 days
Active Comparator: EVP-6124 1.0 mg
one 1.0 mg capsule every day for 84 days.
Placebo Comparator: Placebo
Placebo every day for 84 days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968851
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|Study Director:||Chris Southard||INC Research|