Status:
COMPLETED
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Collaborating Sponsors:
Parexel
Conditions:
Epilepsies, Partial
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Detailed Description
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory parti...
Eligibility Criteria
Inclusion
- Capable of complying with the study procedures.
- Able to provide written informed consent
- Male or female aged 18 to 65 years, inclusive.
- Diagnosis of partial onset seizures
- Minimum of three seizures per 28 days
- Receiving treatment with 1-3 AEDs
- Refractory to at least one AED
- No progressive neurological conditions by recent MRI/CT
- Adequate birth control in women of child-bearing potential
Exclusion
- Refractory to OXC for reasons of efficacy
- Recent status epilepticus
- Recent non-epileptic seizures
- Current diagnosis of major depression
- Recent suicidal plan or intent or more than one attempt
- Current use of oxcarbazepine, felbamate for \< 18 months, phenytoin with levels \>15mcg/mL or frequent need for rescue benzodiazepines
- Current use of sodium-lowering non-seizure medications.
- Clinically significant hepatic, renal, or cardiovascular function
- History of recent substance abuse
- Females who are pregnant or lactating.
- Hypersensitivity to OXC or related drugs
- Difficulty swallowing study medication
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT00772603
Start Date
November 1 2008
End Date
November 1 2010
Last Update
February 11 2014
Active Locations (71)
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Huntsville, Alabama, United States
2
Northport, Alabama, United States
3
Phoenix, Arizona, United States
4
Tucson, Arizona, United States