Clinical trial NCT00968851: Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Central Nervous System Diseases
Cognition
Keywords: Schizophrenia
Central nervous System Diseases
Cognition
Lead sponsor: FORUM Pharmaceuticals Inc
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2009-08-31
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: 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.
timeFrame: 84 days
Secondary outcomes:
measure: Assessment of Clinical Efficacy
timeFrame: 84 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Intergrated Medical and Behavioral Associates
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health
state: Illinois
city: Rockville
country: United States
facility: CBH Health, LLC
state: Maryland
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Psychiatric Hospital
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Arkhangelsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Belgrade
country: Serbia
facility: Clinical Site 1
city: Belgrade
country: Serbia
facility: Clinical Site 2
city: Belgrade
country: Serbia
facility: Clinical Site 3
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Crimea
country: Ukraine
city: Dnipropetrovs'k
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Odessa
country: Ukraine
city: Vinnytsia
country: Ukraine
Study officials:
affiliation: Syneos Health
name: Chris Southard
role: STUDY_DIRECTOR
References:
citation: Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.