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

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01142193

Run by

Upsher-Smith Laboratories

People needed

249

Starts

2010-05-01

Expected to finish

2013-01-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Ventura, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Gulf Breeze, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Lexington, Kentucky, United States
• Study site — Waldorf, Maryland, United States
• Study site — Chesterfield, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Salta, Argentina
• Study site — Villa Nueva, Argentina
• Study site — Bedford Park, Australia
• Study site — Clayton, Australia
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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