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

Condition(s) targeted: Partial Epilepsy

Intervention: Oxcarbazepine (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Supernus Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Paolo Baroldi, MD, PhD, Study Director, Affiliation: Supernus Pharmaceuticals

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

Official title: Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR) as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy on up to Three Concomitant Antiepileptic Medications

Study design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Evaluate the safety and tolerability of long-term administration of oxcarbazepine extended-release in the treatment of seizures of partial origin in subjects with refractory epilepsy on up to three concomitant antiepileptic drugs (AEDs) in adults.

Secondary outcome: To evaluate the effect on seizure frequency of long-term administration of adjunctive OXC XR in the treatment of seizures of partial origin in subjects with refractory epilepsy on other AEDs;To monitor the pattern of dose adjustment over time.

Detailed description: NAP

Minimum age: 18 Years. Maximum age: 66 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

1. Able to provide written informed consent and agree to comply with study procedures.

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

1. 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.

2. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Plovdiv, Bulgaria

Blagoevgrad, Bulgaria

Varna, Bulgaria

Veliko Tarnovo, Bulgaria

Pleven, Bulgaria

Pazardzhik, Bulgaria

Sofia, Bulgaria

Zagreb, Croatia

Rijeka, Croatia

Aguascalientes, Mexico

Konskie, Poland

Krakow, Poland

Warszawa, Poland

Gdansk, Poland

Poznan, Poland

Lodz, Poland

Bialystok, Poland

Szczecin, Poland

Zabrze, Poland

Lipno, Poland

Grodzisk Mazowiecki, Poland

Olsztyn, Poland

Siedlce, Poland

Cluj-Napoca, Romania

Bucharest, Romania

Câmpulung, Romania

Craiova, Romania

Moscow, Russian Federation

Saint-Petersburg, Russian Federation

Novosibirsk, Russian Federation

Smolensk, Russian Federation

Krasnoyarsk, Russian Federation

Ekaterinburg, Russian Federation

Northport, Alabama, United States

Huntsville, Alabama, United States

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Redding, California, United States

Burbank, California, United States

San Jose, California, United States

Oxnard, California, United States

Los Angeles, California, United States

West Los Angeles, California, United States

Santa Monica, California, United States

Fountain Valley, California, United States

Aurora, Colorado, United States

Mexico City, DF, Mexico

Toluca, Estado de Mexico, Mexico

West Palm Beach, Florida, United States

Miami, Florida, United States

Jacksonville, Florida, United States

Boca Raton, Florida, United States

Sarasota, Florida, United States

Atlanta, Georgia, United States

Columbus, Georgia, United States

Boise, Idaho, United States

Elkhart, Indiana, United States

Guadalajara, Jalisco, Mexico

Lexington, Kentucky, United States

Baltimore, Maryland, United States

Roseville, Michigan, United States

Detroit, Michigan, United States

Toms River, New Jersey, United States

New York, New York, United States

San Pedro, Nuevo Leon, Mexico

Monterrey, Nuevo Leon, Mexico

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Johnstown, Pennsylvania, United States

Souderton, Pennsylvania, United States

Greenfield Park, Quebec, Canada

Montreal-Est, Quebec, Canada

Rousse, Ruse, Bulgaria

San Luis Potosi, San Luis Potosí, Mexico

St Petersburg, Sestroretsk, Russian Federation

Nashville, Tennessee, United States

Houston, Texas, United States

Galveston, Texas, United States

Baytown, Texas, United States

Richmond, Virginia, United States

Starting date: June 2009
Ending date: July 2011
Last updated: August 26, 2009