Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968851
• Other study ID #: EVP-6124-009
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2009
• Last updated: March 28, 2014
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: FORUM Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Cognition
• Nervous System Diseases
• Schizophrenia

Intervention

Drug:
• EVP-6124
Arms: 1
• Placebo
Arm: 3
• EVP-6124
Arms: 2

Locations

Country	Name	City	State
Serbia	Clinical Site 1	Belgrade
Serbia	Clinical Site 2	Belgrade
Serbia	Clinical Site 3	Belgrade
United States	FutureSearch Clinical Trials, L.P.	Austin	Texas
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	Uptown Research Institute	Chicago	Illinois
United States	InSite Clinical Research	DeSoto	Texas
United States	Intergrated Medical and Behavioral Associates	Glendale	California
United States	Alexian Brothers Behavioral Health	Hoffman Estates	Illinois
United States	Vanderbilt Psychiatric Hospital	Nashville	Tennessee
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	Excell Research	Oceanside	California
United States	CBH Health, LLC	Rockville	Maryland
United States	Affiliated Research Institute	San Diego	California
United States	University of California, San Diego	San Diego	California
United States	Schuster Medical Research Institute	Sherman Oaks	California
United States	CRI Worldwide	Willingboro	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
FORUM Pharmaceuticals Inc	INC Research

Countries where clinical trial is conducted

United States,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		84 days
Secondary	Assessment of Clinical Efficacy		84 days