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
Overview
- Phase
- Phase 2
- Intervention
- EVP-6124
- Conditions
- Schizophrenia
- Sponsor
- FORUM Pharmaceuticals Inc
- Enrollment
- 317
- Locations
- 17
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
EVP-6124 0.3 mg
one 0.3 mg capsule every day for 84 days
Intervention: EVP-6124
EVP-6124 1.0 mg
one 1.0 mg capsule every day for 84 days.
Intervention: EVP-6124
Placebo
Placebo every day for 84 days
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Assessment of Clinical Efficacy(84 days)