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Phase 3 N=214 Treatment

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

Partial Epilepsy

Enrolled (actual)
214
Serious AEs
8.4%
Results posted
May 2017
Primary outcome: Primary: Percent Change in Seizure Rate — -26.3 percentage of change in seizure rate

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Oxcarbazepine XR (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Supernus Pharmaceuticals, Inc.
Primary completion
Nov 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in Seizure Rate
-26.3

Summary

Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

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.
View full record on ClinicalTrials.gov →

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.

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