Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
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ClinicalTrials.gov Identifier: NCT00908349 |
Recruitment Status :
Completed
First Posted : May 25, 2009
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Partial Epilepsy | Drug: Oxcarbazepine XR | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 214 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Oxcarbazepine XR
Open Label Study
|
Drug: Oxcarbazepine XR
Open Label Study
Other Name: SPN-804O |
- Percent Change in Seizure Rate [ Time Frame: one year ]Measured as change from baseline to end of study

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Ages Eligible for Study: | 18 Years to 66 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908349

Study Director: | Janet K Johnson, PhD | Supernus Pharmaceuticals, Inc. |
Responsible Party: | Supernus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00908349 History of Changes |
Other Study ID Numbers: |
804P302 |
First Posted: | May 25, 2009 Key Record Dates |
Results First Posted: | May 31, 2017 |
Last Update Posted: | May 31, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Additional relevant MeSH terms:
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Oxcarbazepine Anticonvulsants |
Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |