Status:
COMPLETED
Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
Lead Sponsor:
FORUM Pharmaceuticals Inc
Collaborating Sponsors:
Syneos Health
Conditions:
Schizophrenia
Central Nervous System Diseases
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 c...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00968851
Start Date
December 1 2009
End Date
March 1 2011
Last Update
April 25 2014
Active Locations (31)
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1
Intergrated Medical and Behavioral Associates
Glendale, California, United States, 91204
2
Excell Research
Oceanside, California, United States, 92056
3
University of California, San Diego
San Diego, California, United States, 92103
4
Affiliated Research Institute
San Diego, California, United States, 92108