Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Tracking Information
Start Date ICMJE | June 2009 |
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Estimated Primary Completion Date | June 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 History | Complete 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 ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy |
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Official Title ICMJE | Multicenter, 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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Partial Epilepsy |
Intervention ICMJE | Drug: Oxcarbazepine Open Label Study Other Name: NAP |
Study Arms / Comparison Groups | Oxcarbazepine Open Label Study Intervention: Drug: Oxcarbazepine |
Recruitment Information
Estimated Enrollment ICMJE | 360 |
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Estimated Completion Date | July 2011 |
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Gender | Both |
Ages | 18 Years to 66 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | United States, Bulgaria, Canada, Croatia, Mexico, Poland, Romania, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00908349 | ||||
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Responsible Party | Dawn Louro, Supernus Pharmaceuticals | ||||
Study ID Numbers ICMJE | 804P302 | ||||
Study Sponsor ICMJE | Supernus Pharmaceuticals, Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Supernus Pharmaceuticals, Inc. |
Source: http://clinicaltrials.gov/