Clinical trial NCT00419393: Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
Official title: An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Keppra XR
Levetiracetam XR
long term
partial seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-01-08
Enrollment: 190
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.


Eligibility criteria: Inclusion Criteria:

* Subjects who were randomized into study N01280 \[NCT00419094\], and completed the 2 week up titration period

Exclusion Criteria:

* Subjects who did not meet the inclusion/exclusion criteria for N01280 \[NCT00419094\]
* Subjects who were discontinued prior to the end of titration period

Primary outcomes:
measure: Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
timeFrame: Duration of the Treatment Period (6 months-2 years)
measure: Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
timeFrame: Duration of the Treatment Period (6 months-2 years)
measure: Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
timeFrame: Duration of the Treatment Period (6 months-2 years)
Secondary outcomes:
measure: Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
timeFrame: Study entry through 6 months
measure: Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
timeFrame: Study entry through 12 months
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: Loxahatchee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Suwanee
country: United States
state: Georgia
city: Witchita
country: United States
state: Kansas
city: Detroit
country: United States
state: Michigan
city: Camden
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: San Antonio
country: United States
state: Texas
city: Aguascalientes
country: Mexico
city: Guadalajara Jalisco
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Mexico DF
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 (UCB)
name: UCB Clinical Trial Call Center, MD
role: STUDY_DIRECTOR
References: