Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
NCT ID: NCT00908349
Last Updated: 2017-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2009-06-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oxcarbazepine XR
Open Label Study
Oxcarbazepine XR
Open Label Study
Interventions
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Oxcarbazepine XR
Open Label Study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female aged 18 to 66 years, inclusive.
3. Successful completion of the 804P301 study.
4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication \[SM\] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to SM administration\] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.
Exclusion Criteria
2. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
18 Years
66 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Janet K Johnson, PhD
Role: STUDY_DIRECTOR
Supernus Pharmaceuticals, Inc.
Locations
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Huntsville, Alabama, United States
Northport, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Riverside, California, United States
West Los Angeles, California, United States
Aurora, Colorado, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Sarasota, Florida, United States
Springfield, Illinois, United States
Lexington, Kentucky, United States
Bethesda, Maryland, United States
Missoula, Montana, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Nashville, Tennessee, United States
Baytown, Texas, United States
Temple, Texas, United States
Blagoevgrad, , Bulgaria
Pleven, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Greenfield Park, Quebec, Canada
Dubrovnik, , Croatia
Zagreb, , Croatia
Col. Las Palmas, Chihuahua, Mexico
Col. Guillermina, Durango, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Mexico City, Mexico City, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
Aguascalientes, , Mexico
Puebla City, , Mexico
Giżycko, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Warsaw, , Poland
Wilkowice, , Poland
Bucharest, , Romania
Campulung Muscel, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Kazan', , Russia
Kirov, , Russia
Kursk, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Pyatigorsk, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Countries
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Other Identifiers
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804P302
Identifier Type: -
Identifier Source: org_study_id
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