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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00908349
• Date of registration: 22/05/2009
• Prospective Registration: Yes
• Primary sponsor: Supernus Pharmaceuticals, Inc.
• Public title: Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
• Scientific title: Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
• Date of first enrolment: June 2009
• Target sample size: 214
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00908349
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Croatia, Mexico, Poland, Romania, Russian Federation, United States

Contacts

• Name: Janet K Johnson, PhD
• Affiliation: Supernus Pharmaceuticals, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 66 Years
Gender: All

Health Condition(s) or Problem(s) studied

Partial Epilepsy

Intervention(s)

Drug: Oxcarbazepine XR

Primary Outcome(s)

Percent Change in Seizure Rate [Time Frame: one year]

Secondary ID(s)

804P302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00908349