Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.