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

March 28, 2014 updated by: FORUM Pharmaceuticals Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163530
      • Kazan, Russian Federation, 420012
      • Moscow, Russian Federation, 115522
      • Moscow, Russian Federation, 107076
      • St. Petersburg, Russian Federation, 190121
      • Stavropol, Russian Federation, 355108
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Site 1
      • Belgrade, Serbia, 11000
        • Clinical Site 2
      • Belgrade, Serbia, 11000
        • Clinical Site 3
      • Kragujevac, Serbia, 34000
      • Nis, Serbia, 18000
  • Ukraine
      • Crimea, Ukraine, 95006
      • Dnipropetrovs'k, Ukraine, 49005
      • Kiev, Ukraine, 02660
      • Kiev, Ukraine, 04080
      • Odessa, Ukraine, 65014
      • Vinnytsia, Ukraine, 21005
  • United States
    • California
      • Glendale, California, United States, 91204
        • Intergrated Medical and Behavioral Associates
      • Oceanside, California, United States, 92056
        • Excell Research
      • San Diego, California, United States, 92103
        • University of California, San Diego
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • Sherman Oaks, California, United States, 91403
        • Schuster Medical Research Institute
    • Florida
      • North Miami, Florida, United States, 33161
        • Scientific Clinical Research, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research Institute
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Behavioral Health
    • Maryland
      • Rockville, Maryland, United States, 20850
        • CBH Health, LLC
    • New Jersey
      • Willingboro, New Jersey, United States, 20850
        • CRI Worldwide
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Carolina Clinical Trials, Inc.
    • Tennessee
      • Nashville, Tennessee, United States, 37212-8645
        • Vanderbilt Psychiatric Hospital
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Clinical Trials, L.P.
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EVP-6124 0.3 mg
one 0.3 mg capsule every day for 84 days
Drug: EVP-6124
Arms: 1
Drug: EVP-6124
Arms: 2
Active Comparator: EVP-6124 1.0 mg
one 1.0 mg capsule every day for 84 days.
Drug: EVP-6124
Arms: 1
Drug: EVP-6124
Arms: 2
Placebo Comparator: Placebo
Placebo every day for 84 days
Drug: Placebo
Arm: 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
84 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of Clinical Efficacy
Time Frame: 84 days
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FORUM Pharmaceuticals Inc

Collaborators

Syneos Health

Investigators

  • Study Director: Chris Southard, Syneos Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimate)

August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVP-6124-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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