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

Last updated: May 2, 2016
Sponsor: FORUM Pharmaceuticals Inc
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Mild Cognitive Impairment

Dementia

Treatment

N/A

Clinical Study ID

NCT01714713
EVP-6124-017
2012-003228-19
  • Ages 18-50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of the Day 182 visit in a previous 26-week double-blind study (EVP-6124-015or EVP-6124-016).

  • Subject has signed informed consent for this extension study, indicating that thesubject understands the purpose of and procedures required for the study, before theinitiation of any extension study specific procedures. Subjects who are unable toprovide informed consent will not be included in the study

  • No clinically significant changes in the subject's medical status during theparticipation in EVP-6124-015 or EVP-6124-016. Any significant changes in health carestatus and their impact on subject eligibility will be reviewed by the investigatorand sponsor on a case-by-case basis.

  • In the opinion of the investigator, the extension treatment is in the best interest ofthe subject.

  • Fertile, sexually active subjects (men and women) must use an effective method ofcontraception during the study. Females and the female partners of male must besurgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for atleast 1 year, willing to practice adequate methods of contraception if of childbearingpotential (defined as consistent use of combined effective methods of contraception [including at least one barrier method]). Female subjects must have a negative urinepregnancy test predose on Day 1.

Exclusion

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 endorsedon items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS); 2) suicidalbehaviors 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 notresolved, are of moderate or greater severity and judged to be possibly related orrelated to study drug and are thought by the investigator to be contraindications tostudy 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 ineither EVP-6124-015 or EVP-6124-016 other than assigned study medication.

Study Design

Total Participants: 830
Study Start date:
June 01, 2013
Estimated Completion Date:
October 31, 2015

Connect with a study center

  • La Plata, Buenos Aires
    Argentina

    Site Not Available

  • C.a.b.a,
    Argentina

    Site Not Available

  • Mendoza,
    Argentina

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  • Adelaide, South Australia
    Australia

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  • Melbourne, Victoria
    Australia

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  • Mechelen,
    Belgium

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  • Calgary, Alberta
    Canada

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  • Penticton, British Columbia
    Canada

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  • Chatham, Ontario
    Canada

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  • Kingston, Ontario
    Canada

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  • Montreal, Quebec
    Canada

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  • Medellin, Antioquia
    Colombia

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  • Barranquilla, Atlantico
    Colombia

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  • Pereira, Risaralda
    Colombia

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  • Bogota D.C,
    Colombia

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  • Bogota D.C.,
    Colombia

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  • Berlin,
    Germany

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  • Dusseldorf,
    Germany

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  • Leipzig,
    Germany

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  • Mittweida,
    Germany

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  • Stralsund,
    Germany

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  • Catania, CT
    Italy

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  • Roma, RM
    Italy

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  • Milano,
    Italy

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  • Mexico, DF
    Mexico

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  • Guadalajara, Jalisco
    Mexico

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  • Monterrey, Nuevo Leon
    Mexico

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  • Mexico, D.F,
    Mexico

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  • San Luis Potosi,
    Mexico

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  • Belchatow,
    Poland

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  • Campulung, Arges
    Romania

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  • Oradea, Bihor
    Romania

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  • Cluj-Napacu, Cluj
    Romania

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  • Cluj-Napoca, Cluj
    Romania

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  • Palazu-Mare, Constanta
    Romania

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  • Targu Mures, Mures
    Romania

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  • Bucuresti, Sector 4
    Romania

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  • Talagi, Arkhangelsk region
    Russian Federation

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  • Smolensk, Smolensk Region
    Russian Federation

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  • Moscow,
    Russian Federation

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  • Saint Petersburg,
    Russian Federation

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  • Saint-Petersburg,
    Russian Federation

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  • Stavropol,
    Russian Federation

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  • Yaroslavl,
    Russian Federation

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  • Singapore,
    Singapore

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  • Salamanca, Castilla y Leon
    Spain

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  • Zamora, Castilla y Leon
    Spain

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  • Alcorcon, Madrid
    Spain

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  • Coslada, Madrid
    Spain

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  • Madrid,
    Spain

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  • Vil. Stepanivka, Kherson
    Ukraine

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  • Dnipropetrovsk,
    Ukraine

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  • Ivano-Frankivsk,
    Ukraine

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  • Kharkiv,
    Ukraine

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  • Kyiv,
    Ukraine

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  • Lviv,
    Ukraine

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  • Poltara,
    Ukraine

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  • Poltava,
    Ukraine

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  • Vinnytsia,
    Ukraine

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  • London,
    United Kingdom

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  • Little Rock, Arkansas
    United States

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  • Anaheim, California
    United States

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  • Bellflower, California
    United States

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  • Cerritos, California
    United States

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  • Chino, California
    United States

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  • Costa Mesa, California
    United States

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  • Culver City, California
    United States

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  • Downey, California
    United States

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  • Escondido, California
    United States

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  • Garden Grove, California
    United States

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  • Glendale, California
    United States

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  • Los Angeles, California
    United States

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  • Mesa, California
    United States

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  • Norwalk, California
    United States

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  • Oakland, California
    United States

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  • Oceanside, California
    United States

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  • Orange, California
    United States

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  • Riverside, California
    United States

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  • San Diego, California
    United States

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  • San Gabriel, California
    United States

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  • Santa Ana, California
    United States

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  • Sherman Oaks, California
    United States

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  • Torrance, California
    United States

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  • Washington, District of Columbia
    United States

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  • Lauderhill, Florida
    United States

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  • Miami, Florida
    United States

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  • Miami Springs, Florida
    United States

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  • North Miami, Florida
    United States

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  • Oakland Park, Florida
    United States

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  • Orange City, Florida
    United States

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  • Orlando, Florida
    United States

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    Tampa, Florida
    United States

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  • Atlanta, Georgia
    United States

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  • Marietta, Georgia
    United States

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  • Smyrna, Georgia
    United States

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  • Chicago, Illinois
    United States

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  • Oak Brook, Illinois
    United States

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  • Oak Park, Illinois
    United States

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  • Wichita, Kansas
    United States

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  • Lake Charles, Louisiana
    United States

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  • Shreveport, Louisiana
    United States

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  • Boston, Massachusetts
    United States

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  • Minneapolis, Minnesota
    United States

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  • Flowood, Mississippi
    United States

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  • Creve Coeur, Missouri
    United States

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  • O'Fallon, Missouri
    United States

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  • St. Charles, Missouri
    United States

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  • St. Louis, Missouri
    United States

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  • Lincoln, Nebraska
    United States

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  • Omaha, Nebraska
    United States

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  • Nashua, New Hampshire
    United States

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  • Princeton, New Jersey
    United States

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  • Albuquerque, New Mexico
    United States

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    Brooklyn, New York
    United States

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  • Cedarhurst, New York
    United States

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  • Jamaica, New York
    United States

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  • New York, New York
    United States

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    Staten Island, New York
    United States

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  • Charlotte, North Carolina
    United States

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  • Cleveland, Ohio
    United States

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  • Shaker Hts., Ohio
    United States

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  • Oklahoma City, Oklahoma
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    Allentown, Pennsylvania
    United States

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  • Conshohocken, Pennsylvania
    United States

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  • Jenkintown, Pennsylvania
    United States

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  • Norristown, Pennsylvania
    United States

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  • Philadelphia, Pennsylvania
    United States

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  • Phoenixville, Pennsylvania
    United States

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  • Austin, Texas
    United States

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  • Dallas, Texas
    United States

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  • Salt Lake City, Utah
    United States

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  • Bellevue, Washington
    United States

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  • Spokane, Washington
    United States

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