A 26-Week Extension Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

May 2, 2016 updated by: FORUM Pharmaceuticals Inc

A Multicenter 26-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to Two Doses of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive Pro-cognitive Treatment in Subjects With Schizophrenia on Chronic Stable Atypical Antipsychotic Therapy

This study is being conducted to further investigate the safety of prolonged exposure to EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

830

Phase

  • Phase 3

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

  • Argentina
      • C.a.b.a, Argentina
      • Mendoza, Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • Melbourne, Victoria, Australia
  • Belgium
      • Mechelen, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Penticton, British Columbia, Canada
    • Ontario
      • Chatham, Ontario, Canada
      • Kingston, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Colombia
      • Bogota D.C, Colombia
      • Bogota D.C., Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia
    • Risaralda
      • Pereira, Risaralda, Colombia
  • Germany
      • Berlin, Germany
      • Dusseldorf, Germany
      • Leipzig, Germany
      • Mittweida, Germany
      • Stralsund, Germany
  • Italy
      • Milano, Italy
    • CT
      • Catania, CT, Italy
    • RM
      • Roma, RM, Italy
  • Mexico
      • Mexico, D.F, Mexico
      • San Luis Potosi, Mexico
    • DF
      • Mexico, DF, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
  • Poland
      • Belchatow, Poland
  • Romania
    • Arges
      • Campulung, Arges, Romania
    • Bihor
      • Oradea, Bihor, Romania
    • Cluj
      • Cluj-Napacu, Cluj, Romania
      • Cluj-Napoca, Cluj, Romania
    • Constanta
      • Palazu-Mare, Constanta, Romania
    • Mures
      • Targu Mures, Mures, Romania
    • Sector 4
      • Bucuresti, Sector 4, Romania
  • Russian Federation
      • Moscow, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Yaroslavl, Russian Federation
    • Arkhangelsk region
      • Talagi, Arkhangelsk region, Russian Federation
    • Smolensk Region
      • Smolensk, Smolensk Region, Russian Federation
  • Singapore
      • Singapore, Singapore
  • Spain
      • Madrid, Spain
    • Castilla y Leon
      • Salamanca, Castilla y Leon, Spain
      • Zamora, Castilla y Leon, Spain
    • Madrid
      • Alcorcon, Madrid, Spain
      • Coslada, Madrid, Spain
  • Ukraine
      • Dnipropetrovsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Poltara, Ukraine
      • Poltava, Ukraine
      • Vinnytsia, Ukraine
    • Kherson
      • Vil. Stepanivka, Kherson, Ukraine
  • United Kingdom
      • London, United Kingdom
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Bellflower, California, United States
      • Cerritos, California, United States
      • Chino, California, United States
      • Costa Mesa, California, United States
      • Culver City, California, United States
      • Downey, California, United States
      • Escondido, California, United States
      • Garden Grove, California, United States
      • Glendale, California, United States
      • Los Angeles, California, United States
      • Mesa, California, United States
      • Norwalk, California, United States
      • Oakland, California, United States
      • Oceanside, California, United States
      • Orange, California, United States
      • Riverside, California, United States
      • San Diego, California, United States
      • San Gabriel, California, United States
      • Santa Ana, California, United States
      • Sherman Oaks, California, United States
      • Torrance, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Lauderhill, Florida, United States
      • Miami, Florida, United States
      • Miami Springs, Florida, United States
      • North Miami, Florida, United States
      • Oakland Park, Florida, United States
      • Orange City, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
      • Smyrna, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Oak Brook, Illinois, United States
      • Oak Park, Illinois, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Lake Charles, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Flowood, Mississippi, United States
    • Missouri
      • Creve Coeur, Missouri, United States
      • O'Fallon, Missouri, United States
      • St. Charles, Missouri, United States
      • St. Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Jersey
      • Princeton, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Cedarhurst, New York, United States
      • Jamaica, New York, United States
      • New York, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Shaker Hts., Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Conshohocken, Pennsylvania, United States
      • Jenkintown, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Phoenixville, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Washington
      • Bellevue, Washington, United States
      • Spokane, Washington, United States

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of the Day 182 visit in a previous 26-week double-blind study (EVP-6124-015 or EVP-6124-016).
  • Subject has signed informed consent for this extension study, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any extension study specific procedures. Subjects who are unable to provide informed consent will not be included in the study
  • No clinically significant changes in the subject's medical status during the participation in EVP-6124-015 or EVP-6124-016. Any significant changes in health care status and their impact on subject eligibility will be reviewed by the investigator and sponsor on a case-by-case basis.
  • In the opinion of the investigator, the extension treatment is in the best interest of the subject.
  • Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Females and the female partners of male must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1 year, willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least one barrier method]). Female subjects must have a negative urine pregnancy test predose on Day 1.

Exclusion Criteria:

  • Significant risk for suicidal or violent behavior, as determined by the investigator. Significant risk for suicidal behavior is defined as 1) suicidal ideation as endorsed on items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS); 2) suicidal behaviors detected by the C-SSRS; or 3) psychiatric interview and examination.
  • Adverse events from the previous study (EVP-6124-015 or EVP-6124-016) that have not resolved, are of moderate or greater severity and judged to be possibly related or related to study drug and are thought by the investigator to be contraindications to study participation.
  • Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
  • Female subjects who are pregnant.
  • Subjects who received any other investigational treatment during participation in either EVP-6124-015 or EVP-6124-016 other than assigned study medication.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVP-6124 low dose
low dose Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Arm 1, 2
Experimental: EVP-6124, high dose
high dose Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Arm 1, 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
Time Frame: Baseline through Day 182 or Early Termination
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood/chemistry/urinalysis)
Baseline through Day 182 or Early Termination

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination
Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182
Time Frame: Baseline to Day 182 or Early Termination
Baseline to Day 182 or Early Termination

Collaborators and Investigators

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

Sponsor

FORUM Pharmaceuticals Inc

Collaborators

Syneos Health

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

June 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVP-6124-017
  • 2012-003228-19 (EudraCT Number)

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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