Clinical trial NCT00419094: Conversion to Monotherapy Study With Keppra XR for Partial Seizures
Official title: A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Keppra XR
conversion to monotherapy
partial seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-01-08
Enrollment: 228
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 12 to 75 years of age.
* Subjects must have inadequately controlled partial onset epilepsy.
* Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)

Exclusion Criteria:

* A history of status epilepticus in the 6 months preceding randomization.
* Significant medical, psychiatric or neurological illness.
* Intake of benzodiazepines on more than an occasional basis
* History of previous treatment with levetiracetam or sensitivity to levetiracetam.

Primary outcomes:
measure: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
timeFrame: 112 days
Secondary outcomes:
measure: The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
timeFrame: 112 days
measure: The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
timeFrame: 112 days
measure: The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
timeFrame: 112 days
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Loxahatchee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Suwanee
country: United States
state: Georgia
city: Winfield
country: United States
state: Illinois
city: Witchita
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Bethesda
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Camden
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Monaca
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Beaufort
country: United States
state: South Carolina
city: Monterrey
country: Mexico
state: NL
city: Aguascalientes
country: Mexico
city: Distrio federal
country: Mexico
city: Guadalajara Jalisco
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Kalingrad
country: Russian Federation
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Samara
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: +1 877 822 9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Chung S, Ceja H, Gawlowicz J, Avakyan G, McShea C, Schiemann J, Lu S. Levetiracetam extended release conversion to monotherapy for the treatment of patients with partial-onset seizures: a double-blind, randomised, multicentre, historical control study. Epilepsy Res. 2012 Aug;101(1-2):92-102. doi: 10.1016/j.eplepsyres.2012.03.007. Epub 2012 Apr 18.