Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00968851|
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : April 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Central Nervous System Diseases Cognition||Drug: EVP-6124 Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||317 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||March 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968851
Show 31 Study Locations
|Study Director:||Chris Southard||Syneos Health|