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

Upsher-Smith Laboratories249 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

249

Conditions

Epilepsy

Interventions

USL255DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.

Time frame: 11 weeks

Secondary Outcomes

Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.

Time frame: 11 weeks

Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.

Time frame: 3 weeks (weeks 1-3)

Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.

Time frame: 3 weeks (weeks 1-3)

Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.

Time frame: 11 weeks

Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.

Time frame: 3 weeks (weeks 1-3)

Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.

Time frame: 11 weeks

Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.

Time frame: 8 weeks (weeks 4-11)

Data from ClinicalTrials.gov

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Unnamed facility

Phoenix, Arizona, United States

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Ventura, California, United States

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Gainesville, Florida, United States

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Gulf Breeze, Florida, United States

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Jacksonville, Florida, United States

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Pensacola, Florida, United States

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Port Charlotte, Florida, United States

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Boise, Idaho, United States

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Lexington, Kentucky, United States

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Waldorf, Maryland, United States

...and 59 more locations