Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

February 9, 2015 updated by: Upsher-Smith Laboratories

Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

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
      • Toronto, Canada
  • Chile
      • Santiago, Chile
      • Valdivia, Chile
  • Germany
      • Bonn, Germany
      • Munich, Germany
  • Greece
      • Athens, Greece
      • Thessaloniki, Greece
  • India
      • Bangalore, India
      • Dehradun, India
      • Hyderabad, India
      • Mangalore, India
      • Mumbai, India
      • New Delhi, India
  • Israel
      • Ashkelon, Israel
      • Holon, Israel
      • Nahariya, Israel
      • Petach Tikva, Israel
      • Ramat Gan, Israel
  • New Zealand
      • Auckland, New Zealand
  • Poland
      • Gdansk, Poland
      • Katowice, 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
      • Valencia, Spain
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Ventura, California, United States
    • Florida
      • Gainsville, Florida, United States
      • Gulf Breeze, Florida, United States
      • Jacksonville, Florida, United States
      • Port Charlotte, Florida, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Waldorf, Maryland, United States
    • Missouri
      • Chesterfield, Missouri, United States
      • St Louis, Missouri, United States
    • New Jersey
      • Somerset, New Jersey, 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:

  • Have completed the maintenance period of the P09-004 study.
  • Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label USL255
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Drug: USL255
Other Names:
  • Topiramate extended-release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Time Frame: Open label treatment of up to 62 weeks
Open label treatment of up to 62 weeks

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

October 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P09-005

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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