Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

Completed · Phase 3

Conditions studied: Partial Epilepsy

In brief

Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Key facts

Study ID

NCT00908349

Run by

Supernus Pharmaceuticals, Inc.

People needed

214

Starts

2009-06-01

Expected to finish

2011-11-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide written informed consent and agree to comply with study procedures.
• Male or female aged 18 to 66 years, inclusive.
• Successful completion of the 804P301 study.
• 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.

You may not qualify if…

• Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

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 — Springfield, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Bethesda, Maryland, United States
• Study site — Missoula, Montana, United States
• Study site — New York, New York, United States
• Study site — Oklahoma City, Oklahoma, 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 — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Varna, Bulgaria
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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