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
NCT ID: NCT01714713
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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COMPLETED
PHASE3
830 participants
INTERVENTIONAL
2013-06-30
2015-10-31
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
TRIPLE
Study Groups
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EVP-6124 low dose
low dose Tablet, Once Daily, Day 1 through Day 182
EVP-6124
Arm 1, 2
EVP-6124, high dose
high dose Tablet, Once Daily, Day 1 through Day 182
EVP-6124
Arm 1, 2
Interventions
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EVP-6124
Arm 1, 2
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Syneos Health
OTHER
FORUM Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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Little Rock, Arkansas, United States
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
Washington D.C., District of Columbia, United States
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
Atlanta, Georgia, United States
Marietta, Georgia, United States
Smyrna, Georgia, United States
Chicago, Illinois, United States
Oak Brook, Illinois, United States
Oak Park, Illinois, United States
Wichita, Kansas, United States
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Flowood, Mississippi, United States
Creve Coeur, Missouri, United States
O'Fallon, Missouri, United States
Saint Charles, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Nashua, New Hampshire, United States
Princeton, New Jersey, United States
Albuquerque, New Mexico, United States
Cedarhurst, New York, United States
Jamaica, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Shaker Hts., Ohio, United States
Oklahoma City, Oklahoma, United States
Conshohocken, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Bellevue, Washington, United States
Spokane, Washington, United States
La Plata, Buenos Aires, Argentina
Mendoza, Mendoza Province, Argentina
C.a.b.a, , Argentina
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Mechelen, , Belgium
Calgary, Alberta, Canada
Penticton, British Columbia, Canada
Chatham, Ontario, Canada
Kingston, Ontario, Canada
Montreal, Quebec, Canada
Medellín, Antioquia, Colombia
Barranquilla, Atlántico, Colombia
Pereira, Risaralda Department, Colombia
Bogota D.C., , Colombia
Bogota D.C, , Colombia
Berlin, , Germany
Düsseldorf, , Germany
Leipzig, , Germany
Mittweida, , Germany
Stralsund, , Germany
Catania, CT, Italy
Milan, Milano, Italy
Roma, RM, Italy
Guadalajara, Jalisco, Mexico
Mexico City, Mexico City, Mexico
Monterrey, Nuevo León, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
Mexico City, , Mexico
Bełchatów, , Poland
Campulung Muscel, Argeş, Romania
Oradea, Bihor County, Romania
Cluj-Napacu, Cluj, Romania
Cluj-Napoca, Cluj, Romania
Palazu Mare, Constanța County, Romania
Târgu Mureş, Mureș County, Romania
Bucharest, Sector 4, Romania
Talagi, Arkhangelskaya oblast, Russia
Smolensk, Smolensk Oblast, Russia
Moscow, , Russia
Saint Petersburg, , Russia
Stavropol, , Russia
Yaroslavl, , Russia
Singapore, Singapore, Singapore
Salamanca, Castille and León, Spain
Zamora, Castille and León, Spain
Alcorcón, Madrid, Spain
Coslada, Madrid, Spain
Madrid, Madrid, Spain
Vil. Stepanivka, Kherson Oblast, Ukraine
Dnipropetrovsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Poltara, , Ukraine
Poltava, , Ukraine
Vinnytsia, , Ukraine
London, , United Kingdom
Countries
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Other Identifiers
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2012-003228-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EVP-6124-017
Identifier Type: -
Identifier Source: org_study_id
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