Status:
COMPLETED
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Partial Epilepsy
Eligibility:
All Genders
18-66 years
Phase:
PHASE3
Brief Summary
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
Detailed Description
NAP
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00908349
Start Date
June 1 2009
End Date
November 1 2011
Last Update
May 31 2017
Active Locations (58)
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1
Huntsville, Alabama, United States
2
Northport, Alabama, United States
3
Phoenix, Arizona, United States
4
Tucson, Arizona, United States