Back to resultsOpen-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
USL255
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, partial onset seizure, adjunctive therapy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label USL255
Arm Description
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Outcomes
Primary Outcome Measures
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Secondary Outcome Measures
Full Information
NCT ID
NCT01191086
First Posted
August 26, 2010
Last Updated
February 9, 2015
Sponsor
Upsher-Smith Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01191086
Brief Title
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Upsher-Smith Laboratories
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, partial onset seizure, adjunctive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-label USL255
Arm Type
Experimental
Arm Description
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Intervention Type
Drug
Intervention Name(s)
USL255
Other Intervention Name(s)
Topiramate extended-release
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Ventura
State/Province
California
Country
United States
City
Gainsville
State/Province
Florida
Country
United States
City
Gulf Breeze
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Port Charlotte
State/Province
Florida
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Waldorf
State/Province
Maryland
Country
United States
City
Chesterfield
State/Province
Missouri
Country
United States
City
St Louis
State/Province
Missouri
Country
United States
City
Somerset
State/Province
New Jersey
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
Guaymallen
Country
Argentina
City
Salta
Country
Argentina
City
Bedford Park
Country
Australia
City
Clayton
Country
Australia
City
Fitzory
Country
Australia
City
Heidelberg West
Country
Australia
City
Parkville
Country
Australia
City
Randwick
Country
Australia
City
Woodville
Country
Australia
City
Brugge
Country
Belgium
City
Duffel
Country
Belgium
City
Leuven
Country
Belgium
City
Greenfield Park
Country
Canada
City
Toronto
Country
Canada
City
Santiago
Country
Chile
City
Valdivia
Country
Chile
City
Bonn
Country
Germany
City
Munich
Country
Germany
City
Athens
Country
Greece
City
Thessaloniki
Country
Greece
City
Bangalore
Country
India
City
Dehradun
Country
India
City
Hyderabad
Country
India
City
Mangalore
Country
India
City
Mumbai
Country
India
City
New Delhi
Country
India
City
Ashkelon
Country
Israel
City
Holon
Country
Israel
City
Nahariya
Country
Israel
City
Petach Tikva
Country
Israel
City
Ramat Gan
Country
Israel
City
Auckland
Country
New Zealand
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Warszawa
Country
Poland
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Samara
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Tyumen
Country
Russian Federation
City
Yaroslavi
Country
Russian Federation
City
Cape Town
Country
South Africa
City
Badalona
Country
Spain
City
Baracaldo
Country
Spain
City
Granada
Country
Spain
City
Madrid
Country
Spain
City
Valencia
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27084978
Citation
Chung SS, Hogan RE, Blatt I, Lawson P B, Nguyen H, Clark AM, Anders B, Halvorsen MB; PREVAIL OLE Study Group. Long-term safety and sustained efficacy of USL255 (topiramate extended-release capsules) in patients with refractory partial-onset seizures. Epilepsy Behav. 2016 Jun;59:13-20. doi: 10.1016/j.yebeh.2016.03.005. Epub 2016 Apr 14.
Results Reference
derived
Learn more about this trial
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
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