Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures

Upsher-Smith Laboratories

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Treatments

Drug: USL255

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01142193

P09-004

2009-016996-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Enrollment

249 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.