Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsies, Partial

In brief

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Key facts

Study ID

NCT00772603

Run by

Supernus Pharmaceuticals, Inc.

People needed

366

Starts

2008-11-01

Expected to finish

2010-11-01

Last updated by the study team

2014-02-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of complying with the study procedures.
• 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

You may not qualify if…

• Refractory to OXC for reasons of efficacy
• 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

Where it is running

• Study site — Northport, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Riverside, California, United States
• Study site — West Los Angeles, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Springfield, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Bethesda, Maryland, United States
• Study site — Missoula, Montana, United States
• Study site — Camden, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Baytown, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Blagoevgrad, Bulgaria
• Study site — Pleven, Bulgaria
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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