Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
NCT ID: NCT00772603
Last Updated: 2014-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
366 participants
INTERVENTIONAL
2008-11-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo - four identical tablets taken orally once daily
Placebo
Non-active tablet identical to study drug tablets
2400 mg SPN-804
2400mg OXC XR taken orally once daily as four identical tablets
2400mg SPN-804
tablets containing 600mg OXC XR, identical to non-active tablets
1200mg SPN-804
1200mg OXC XR taken orally once daily as four identical tablets
1200mg SPN-804
two active tablets and two non-active tablets, all identical
Interventions
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Placebo
Non-active tablet identical to study drug tablets
2400mg SPN-804
tablets containing 600mg OXC XR, identical to non-active tablets
1200mg SPN-804
two active tablets and two non-active tablets, all identical
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent
* Male or female aged 18 to 65 years, inclusive.
* Diagnosis of partial onset seizures
* Minimum of three seizures per 28 days
* Receiving treatment with 1-3 AEDs
* Refractory to at least one AED
* No progressive neurological conditions by recent MRI/CT
* Adequate birth control in women of child-bearing potential
Exclusion Criteria
* Recent status epilepticus
* Recent non-epileptic seizures
* Current diagnosis of major depression
* Recent suicidal plan or intent or more than one attempt
* Current use of oxcarbazepine, felbamate for \< 18 months, phenytoin with levels \>15mcg/mL or frequent need for rescue benzodiazepines
* Current use of sodium-lowering non-seizure medications.
* Clinically significant hepatic, renal, or cardiovascular function
* History of recent substance abuse
* Females who are pregnant or lactating.
* Hypersensitivity to OXC or related drugs
* Difficulty swallowing study medication
18 Years
65 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
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
Atlanta, Georgia, United States
Springfield, Illinois, United States
Lexington, Kentucky, United States
Bethesda, Maryland, United States
Missoula, Montana, United States
Camden, New Jersey, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Baytown, Texas, United States
Temple, Texas, United States
Blagoevgrad, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Edmonton, Alberta, Canada
Greenfield Park, Quebec, Canada
Dubrovnik, , Croatia
Rijeka, , Croatia
Zadar, , Croatia
Zagreb, , Croatia
Aguascalientes, Aguascalientes, Mexico
Chihuahua City, Chihuahua, Mexico
Ciudad Juárez, Chihuahua, Mexico
Durango, Durango, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Mexico City, Mexico City, Mexico
Monterrey, Nuevo León, Mexico
Puebla City, Puebla, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
Toluca, State of Mexico, Mexico
Giżycko, , Poland
Gmina Końskie, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Warsaw, , Poland
Wilkowice, , Poland
Zabrze, , Poland
Bucharest, , Romania
Campulung Muscel, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Saint Petersburg, Sestroretsk, Russia
Kazan', , Russia
Kirov, , Russia
Kursk, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Pyatigorsk, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Yaroslavl, , Russia
Countries
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Other Identifiers
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804P301
Identifier Type: -
Identifier Source: org_study_id
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