Clinical trial NCT01142193: Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
partial onset seizure
adjunctive therapy
Lead sponsor: Upsher-Smith Laboratories
Sponsor class: INDUSTRY
First posted: 2010-06-11
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
timeFrame: 11 weeks
Secondary outcomes:
measure: 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.
timeFrame: 11 weeks
measure: Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
timeFrame: 3 weeks (weeks 1-3)
measure: Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
timeFrame: 3 weeks (weeks 1-3)
measure: Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.
timeFrame: 11 weeks
measure: Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.
timeFrame: 3 weeks (weeks 1-3)
measure: 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.
timeFrame: 11 weeks
measure: Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
timeFrame: 8 weeks (weeks 4-11)
measure: Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
timeFrame: 8 weeks (weeks 4-11)
measure: Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
timeFrame: 8 weeks (weeks 4-11)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Ventura
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Gulf Breeze
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Lexington
country: United States
state: Kentucky
city: Waldorf
country: United States
state: Maryland
city: Chesterfield
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: New Brunswick
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
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: Santiago
country: Chile
city: Valdivia
country: Chile
city: Bonn
country: Germany
city: Munchen
country: Germany
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Bangalore
country: India
city: Dehradun
country: India
city: Hyderabad
country: India
city: Mangalore
country: India
city: New Delhi
country: India
city: Ashkelon
country: Israel
city: Haifa
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: 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
Study officials:
References:
citation: 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.
citation: Chung 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.