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

• Conditions: Treatment of seizures of partial origin in subjects with refractory epilepsy; MedDRA version: 9.1Level: LLTClassification code 10015037Term: Epilepsy

• Registration Number: EUCTR2008-003334-19-BG
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the safety and tolerability of long-term administration<br>of adjunctive oxcarbazepine extended-release (OXC XR) in the treatment of seizures of partial origin<br>in subjects with refractory epilepsy on up to three concomitant antiepileptic drugs (AEDs) in adults.;Secondary Objective: The secondary objectives are:<br>• To evaluate the effect on seizure frequency of long-term administration of adjunctive OXC XR<br>in the treatment of seizures of partial origin in subjects with refractory epilepsy on other AEDs;<br>and<br>• To monitor the pattern of dose adjustment over time.;Primary end point(s): The percentage change (PCH) in partial seizure frequency per 28 days during the Treatment Phase (excluding the 3-week Tapering) relative to the 804P301 Baseline Phase and the 804P301 Maintenance Period in the ITT population.