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

May 19, 2014 updated by: Upsher-Smith Laboratories

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Cordoba, Argentina
      • Guaymallen, Argentina
      • Salta, Argentina
  • Australia
      • Bedford Park, Australia
      • Clayton, Australia
      • Fitzory, Australia
      • Heidelberg West, Australia
      • Parkville, Australia
      • Randwick, Australia
      • Woodville, Australia
  • Belgium
      • Brugge, Belgium
      • Duffel, Belgium
      • Leuven, Belgium
  • Canada
      • Greenfield Park, Canada
  • Chile
      • Santiago, Chile
      • Valdivia, Chile
  • Germany
      • Bonn, Germany
      • Munchen, Germany
  • Greece
      • Athens, Greece
      • Thessaloniki, Greece
  • Hungary
      • Budapest, Hungary
  • India
      • Bangalore, India
      • Dehradun, India
      • Hyderabad, India
      • Mangalore, India
      • New Delhi, India
  • Israel
      • Ashkelon, Israel
      • Haifa, Israel
      • Holon, Israel
      • Nahariya, Israel
      • Petach Tikva, Israel
      • Ramat Gan, Israel
  • New Zealand
      • Auckland, New Zealand
  • Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Warszawa, Poland
  • Russian Federation
      • Kazan, Russian Federation
      • Moscow, Russian Federation
      • Samara, Russian Federation
      • St. Petersburg, Russian Federation
      • Tyumen, Russian Federation
      • Yaroslavi, Russian Federation
  • South Africa
      • Cape Town, South Africa
  • Spain
      • Badalona, Spain
      • Baracaldo, Spain
      • Granada, Spain
      • Madrid, Spain
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Ventura, California, United States
    • Florida
      • Gainesville, Florida, United States
      • Gulf Breeze, Florida, United States
      • Jacksonville, Florida, United States
      • Pensacola, Florida, United States
      • Port Charlotte, Florida, United States
    • Idaho
      • Boise, Idaho, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Waldorf, Maryland, United States
    • Missouri
      • Chesterfield, Missouri, United States
      • St. Louis, Missouri, United States
    • New Jersey
      • New Brunswick, New Jersey, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Toledo, Ohio, United States
    • Texas
      • Dallas, Texas, United States
      • Temple, Texas, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: USL255
Drug: USL255

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
11 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
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)
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
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)
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
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)
8 weeks (weeks 4-11)
Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
Time Frame: 8 weeks (weeks 4-11)
8 weeks (weeks 4-11)
Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
Time Frame: 8 weeks (weeks 4-11)
8 weeks (weeks 4-11)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Upsher-Smith Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P09-004
  • 2009-016996-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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