Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
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
2 other identifiers
interventional
249
16 countries
69
Brief Summary
The purpose of this study is to examine the safety and effectiveness 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 P50-P75 for phase_3
Started May 2010
Typical duration for phase_3
69 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
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
May 7, 2014
CompletedMay 22, 2014
May 1, 2014
2.6 years
June 9, 2010
April 3, 2014
May 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
11 weeks
Secondary Outcomes (9)
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.
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.
3 weeks (weeks 1-3)
Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
3 weeks (weeks 1-3)
Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.
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.
3 weeks (weeks 1-3)
- +4 more secondary outcomes
Study Arms (2)
USL255
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Ventura, California, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Gulf Breeze, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Pensacola, Florida, United States
Unknown Facility
Port Charlotte, Florida, United States
Unknown Facility
Boise, Idaho, 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
New Brunswick, New Jersey, United States
Unknown Facility
New York, New York, 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
Córdoba, 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
Santiago, Chile
Unknown Facility
Valdivia, Chile
Unknown Facility
Bonn, Germany
Unknown Facility
München, Germany
Unknown Facility
Athens, Greece
Unknown Facility
Thessaloniki, Greece
Unknown Facility
Budapest, Hungary
Unknown Facility
Bangalore, India
Unknown Facility
Dehradun, India
Unknown Facility
Hyderabad, India
Unknown Facility
Mangalore, India
Unknown Facility
New Delhi, India
Unknown Facility
Ashkelon, Israel
Unknown Facility
Haifa, 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
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
Related Publications (2)
Hogan RE, Blatt I, Lawson B, Nagaraddi V, Fakhoury TA, Anders B, Clark AM, Laine D, Halvorsen MB, Chung SS. Efficacy of once-daily extended-release topiramate (USL255): a subgroup analysis based on the level of treatment resistance. Epilepsy Behav. 2014 Dec;41:136-9. doi: 10.1016/j.yebeh.2014.09.061. Epub 2014 Oct 21.
PMID: 25461205DERIVEDChung SS, Fakhoury TA, Hogan RE, Nagaraddi VN, Blatt I, Lawson B, Arnold S, Anders B, Clark AM, Laine D, Meadows RS, Halvorsen MB; PREVAIL Study Group. Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized phase III study. Epilepsia. 2014 Jul;55(7):1077-87. doi: 10.1111/epi.12660. Epub 2014 Jun 5.
PMID: 24902983DERIVED
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
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2010
First Posted
June 11, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
May 22, 2014
Results First Posted
May 7, 2014
Record last verified: 2014-05