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

This study has been completed.
Information provided by (Responsible Party):
Upsher-Smith Laboratories Identifier:
First received: June 9, 2010
Last updated: February 5, 2014
Last verified: February 2014

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

Condition Intervention Phase
Drug: USL255
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.

Secondary Outcome Measures:
  • 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.
  • Proportions of subjects with ≥50% reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.
  • Percent reductions from baseline in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.
  • Percent reduction from baseline in weekly (7 day) all seizure frequency during the titration plus maintenance phase.
  • Proportions of subjects with ≥25%, ≥75%, and 100% reduction in weekly (7 day) partial-onset seizure frequency during the titration, maintenance and titration plus maintenance phases, separately.

Enrollment: 249
Study Start Date: May 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL255 Drug: USL255
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01142193

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United States, Arizona
Phoenix, Arizona, United States
United States, California
Ventura, California, United States
United States, Florida
Gainesville, Florida, United States
Gulf Breeze, Florida, United States
Jacksonville, Florida, United States
Pensacola, Florida, United States
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Boise, Idaho, United States
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Lexington, Kentucky, United States
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New York, New York, United States
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Milwaukee, Wisconsin, United States
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Bedford Park, Australia
Clayton, Australia
Fitzory, Australia
Heidelberg West, Australia
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Brugge, Belgium
Duffel, Belgium
Leuven, Belgium
Greenfield Park, Canada
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Bonn, Germany
Munchen, Germany
Athens, Greece
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Budapest, Hungary
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Dehradun, India
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Mangalore, India
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South Africa
Cape Town, South Africa
Badalona, Spain
Baracaldo, Spain
Granada, Spain
Madrid, Spain
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided

Responsible Party: Upsher-Smith Laboratories Identifier: NCT01142193     History of Changes
Other Study ID Numbers: P09-004, 2009-016996-31
Study First Received: June 9, 2010
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
partial onset seizure
adjunctive therapy

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on April 16, 2014