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COMPLETEDPHASE3

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

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

NCT01142193•Upsher-Smith Laboratories

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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.

Locations (69)

Phoenix, Arizona, United States

Ventura, California, United States

Gainesville, Florida, United States

Gulf Breeze, Florida, United States

Jacksonville, Florida, United States

Pensacola, Florida, United States

Port Charlotte, Florida, United States

Boise, Idaho, United States

Lexington, Kentucky, United States

Waldorf, Maryland, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

December 1, 2012

Completion Date

January 1, 2013

Last Updated

May 22, 2014

Enrollment

249

ACTUAL participants

Conditions

Epilepsy

Interventions

USL255

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers