Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
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
1 other identifier
interventional
210
15 countries
68
Brief Summary
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2010
Typical duration for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
February 23, 2015
CompletedFebruary 23, 2015
February 1, 2015
3.6 years
August 26, 2010
February 9, 2015
February 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Open label treatment of up to 62 weeks
Study Arms (1)
Open-label USL255
EXPERIMENTALTopiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Ventura, California, United States
Unknown Facility
Gainsville, Florida, United States
Unknown Facility
Gulf Breeze, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Port Charlotte, Florida, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Waldorf, Maryland, United States
Unknown Facility
Chesterfield, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Somerset, New Jersey, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Temple, Texas, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
CĂ³rdoba, Argentina
Unknown Facility
Salta, Argentina
Unknown Facility
Villa Nueva, Argentina
Unknown Facility
Bedford Park, Australia
Unknown Facility
Clayton, Australia
Unknown Facility
Fitzory, Australia
Unknown Facility
Heidelberg West, Australia
Unknown Facility
Parkville, Australia
Unknown Facility
Randwick, Australia
Unknown Facility
Woodville, Australia
Unknown Facility
Bruges, Belgium
Unknown Facility
Duffel, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Greenfield Park, Canada
Unknown Facility
Toronto, Canada
Unknown Facility
Santiago, Chile
Unknown Facility
Valdivia, Chile
Unknown Facility
Bonn, Germany
Unknown Facility
Munich, Germany
Unknown Facility
Athens, Greece
Unknown Facility
Thessaloniki, Greece
Unknown Facility
Bangalore, India
Unknown Facility
Dehradun, India
Unknown Facility
Hyderabad, India
Unknown Facility
Mangalore, India
Unknown Facility
Mumbai, India
Unknown Facility
New Delhi, India
Unknown Facility
Ashkelon, Israel
Unknown Facility
Holon, Israel
Unknown Facility
Nahariya, Israel
Unknown Facility
Petah Tikva, Israel
Unknown Facility
Ramat Gan, Israel
Unknown Facility
Auckland, New Zealand
Unknown Facility
Gdansk, Poland
Unknown Facility
Katowice, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Kazan', Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Tyumen, Russia
Unknown Facility
Yaroslavi, Russia
Unknown Facility
Cape Town, South Africa
Unknown Facility
Badalona, Spain
Unknown Facility
Barakaldo, Spain
Unknown Facility
Granada, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Valencia, Spain
Related Publications (1)
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.
PMID: 27084978DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bob Anders, Sr. Director of Clinical Operations
- Organization
- Upsher-Smith Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
August 30, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 23, 2015
Results First Posted
February 23, 2015
Record last verified: 2015-02