Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025
NCT ID: NCT02004392
Last Updated: 2016-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
348 participants
INTERVENTIONAL
2014-06-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EVP-6124, low dose
low dose, Tablet, Once Daily, Day 1 through Day 182
EVP-6124
EVP-6124, high dose
high dose, Tablet, Once Daily, Day 1 through Day 182
EVP-6124
Interventions
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EVP-6124
Eligibility Criteria
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Inclusion Criteria
* Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures
* Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
* No clinically significant change in the judgment of the investigator in the subject's medical status during study EVP-6124-024 or EVP-6124-025
* In the judgment of the investigator, 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. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception \[including at least 1 barrier method\])
* Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible
Exclusion Criteria
* Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
* Any condition that would make the subject in the judgment of the investigator unsuitable for the study
* Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study
55 Years
85 Years
ALL
No
Sponsors
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FORUM Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Costa Mesa, California, United States
Culver City, California, United States
Encino, California, United States
Glendale, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Orange, California, United States
Redding, California, United States
San Diego, California, United States
New Haven, Connecticut, United States
Norwich, Connecticut, United States
Atlantis, Florida, United States
Brooksville, Florida, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Hallandale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Sunrise, Florida, United States
West Palm Beach, Florida, United States
Columbus, Georgia, United States
Park Ridge, Illinois, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Bangor, Maine, United States
Newton, Massachusetts, United States
Plymouth, Massachusetts, United States
Flowood, Mississippi, United States
Hattiesburg, Mississippi, United States
Creve Coeur, Missouri, United States
Princeton, New Jersey, United States
Springfield, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Cedarhurst, New York, United States
Latham, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Norristown, Pennsylvania, United States
Plains, Pennsylvania, United States
East Providence, Rhode Island, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Bennington, Vermont, United States
Charlottesville, Virginia, United States
Williamsburg, Virginia, United States
Richland, Washington, United States
Geelong, Victoria, Australia
Leuven, , Belgium
Kelowna, British Columbia, Canada
Halifax, Nova Scotia, Canada
Chatham, Ontario, Canada
Toronto, Ontario, Canada
Prague, , Czechia
Rychnov nad Kněžnou, , Czechia
Milan, Lombardy, Italy
Amsterdam, , Netherlands
Bialystok, , Poland
Warsaw, , Poland
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Bellville, Western Cape, South Africa
George, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Busan, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Terrassa, Barcelona, Spain
Burgos, , Spain
Madrid, , Spain
Salamanca, , Spain
Glasgow, , United Kingdom
Isleworth, , United Kingdom
Northampton, , United Kingdom
Penarth, , United Kingdom
Southampton, , United Kingdom
Countries
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Other Identifiers
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2013-002654-75
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EVP-6124-026
Identifier Type: -
Identifier Source: org_study_id
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