Phase 3
Completed N=214
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Partial Epilepsy
Source: ClinicalTrials.gov NCT00908349 ↗
Enrolled (actual)
214
Serious AEs
8.4%
Results posted
May 2017
Primary outcomePrimary: Percent Change in Seizure Rate — -26.3 percentage of change in seizure rate
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Seizure Rate |
-26.3 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00908349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.