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

Information source: FORUM Pharmaceuticals Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Central Nervous System Diseases; Cognition

Intervention: EVP-6124 (Drug); Placebo (Drug); EVP-6124 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: FORUM Pharmaceuticals Inc

Official(s) and/or principal investigator(s):
Chris Southard, Study Director, Affiliation: INC Research

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Assessment of Clinical Efficacy

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Arkhangelsk 163530, Russian Federation

Kazan 420012, Russian Federation

Moscow 107076, Russian Federation

Moscow 115522, Russian Federation

St. Petersburg 190121, Russian Federation

Stavropol 355108, Russian Federation

Clinical Site 1, Belgrade 11000, Serbia

Clinical Site 2, Belgrade 11000, Serbia

Clinical Site 3, Belgrade 11000, Serbia

Kragujevac 34000, Serbia

Nis 18000, Serbia

Crimea 95006, Ukraine

Dnipropetrovs'k 49005, Ukraine

Kiev 02660, Ukraine

Kiev 04080, Ukraine

Odessa 65014, Ukraine

Vinnytsia 21005, Ukraine

Intergrated Medical and Behavioral Associates, Glendale, California 91204, United States

Excell Research, Oceanside, California 92056, United States

Affiliated Research Institute, San Diego, California 92108, United States

University of California, San Diego, San Diego, California 92103, United States

Schuster Medical Research Institute, Sherman Oaks, California 91403, United States

Scientific Clinical Research, Inc., North Miami, Florida 33161, United States

Uptown Research Institute, Chicago, Illinois 60640, United States

Alexian Brothers Behavioral Health, Hoffman Estates, Illinois 60169, United States

CBH Health, LLC, Rockville, Maryland 20850, United States

CRI Worldwide, Willingboro, New Jersey 20850, United States

Carolina Clinical Trials, Inc., Charleston, South Carolina 29407, United States

Vanderbilt Psychiatric Hospital, Nashville, Tennessee 37212-8645, United States

FutureSearch Clinical Trials, L.P., Austin, Texas 78756, United States

InSite Clinical Research, DeSoto, Texas 75115, United States

Additional Information

Starting date: December 2009
Last updated: March 28, 2014

Page last updated: August 23, 2015

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