Status:
COMPLETED
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Lead Sponsor:
Upsher-Smith Laboratories
Conditions:
Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Eligibility Criteria
Inclusion
- Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
- Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
- Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.
Exclusion
- Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
- Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
- Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
- Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
- Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
- Have taken topiramate within the past 6 months.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT01142193
Start Date
May 1 2010
End Date
January 1 2013
Last Update
May 22 2014
Active Locations (69)
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Phoenix, Arizona, United States
2
Ventura, California, United States
3
Gainesville, Florida, United States
4
Gulf Breeze, Florida, United States