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

Supernus Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Partial Epilepsy

Treatments

Drug: Oxcarbazepine XR

Study type

Interventional

Funder types

Industry

Identifiers

804P302

Details and patient eligibility

About

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

Full description

NAP

Enrollment

214 patients

Sex

All

Ages

18 to 66 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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.

Exclusion Criteria

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.