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


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 26, 2009)		Evaluate the safety and tolerability of long-term administration of oxcarbazepine extended-release in the treatment of seizures of partial origin in subjects with refractory epilepsy on up to three concomitant antiepileptic drugs (AEDs) in adults. [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: May 22, 2009)		Evaluate the safety and tolerability of long-term administration of adjunctive OXC XR in the treatment of seizures of partial origin in subjects with refractory epilepsy on up to two concomitant antiepileptic drugs (AEDs). [ Designated as safety issue: Yes ]
Change HistoryComplete list of historical versions of study NCT00908349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 22, 2009)		To evaluate the effect on seizure frequency of long-term administration of adjunctive OXC XR in the treatment of seizures of partial origin in subjects with refractory epilepsy on other AEDs;To monitor the pattern of dose adjustment over time. [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Official Title  ICMJEMulticenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR) as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy on up to Three Concomitant Antiepileptic Medications
Brief Summary

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

Detailed Description

NAP

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEPartial Epilepsy
Intervention  ICMJEDrug: Oxcarbazepine
Open Label Study
Other Name: NAP
Study Arms / Comparison GroupsOxcarbazepine
Open Label Study
Intervention: Drug: Oxcarbazepine

Recruitment Information

Estimated Enrollment  ICMJE360
Estimated Completion DateJuly 2011
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years to 66 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJEUnited States,   Bulgaria,   Canada,   Croatia,   Mexico,   Poland,   Romania,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00908349
Responsible PartyDawn Louro, Supernus Pharmaceuticals
Study ID Numbers  ICMJE804P302
Study Sponsor  ICMJESupernus Pharmaceuticals, Inc.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Paolo Baroldi, MD, PhDSupernus Pharmaceuticals
Information Provided BySupernus Pharmaceuticals, Inc.