Clinical trial NCT01191086: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
partial onset seizure
adjunctive therapy
Lead sponsor: Upsher-Smith Laboratories
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
timeFrame: Open label treatment of up to 62 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Ventura
country: United States
state: California
city: Gainsville
country: United States
state: Florida
city: Gulf Breeze
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
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: Somerset
country: United States
state: New Jersey
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: 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
Study officials:
References:
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.