Clinical trial NCT00368069: A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Official title: A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Keppra® XR
Levetiracetam XR
Extended release
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 158
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of refractory epilepsy
* Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
* Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Exclusion Criteria:

* Seizures occurring in clusters
* Status epilepticus within 3 months of Visit 1
* History of non-epileptic seizures
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control

Primary outcomes:
measure: Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
timeFrame: Treatment period (12 weeks)
measure: Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
timeFrame: Treatment Period (12 weeks)
Secondary outcomes:
measure: POS Seizure Frequency Per Week Over Baseline and Treatment Period
timeFrame: Baseline Period (8 weeks) - Treatment Period (12 weeks)
measure: All (Type I+II+III) Seizures Frequency Per Week
timeFrame: Treatment period (12 weeks)
measure: 50% Response in Weekly POS Frequency
timeFrame: Treatment period (12 weeks)
measure: Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
timeFrame: over the treatment period (12 weeks)
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: N01235 1007
city: Kuopio
country: Finland
facility: N01235 2001
city: Tampere
country: Finland
facility: N01235 2003
city: Turku
country: Finland
facility: N01235 2002
city: Chennai
country: India
facility: N01235 3008
city: Chennai
country: India
facility: N01235 3010
city: Ghandinagar
country: India
facility: N01235 3012
city: Hyderabad
country: India
facility: N01235 3003
city: Hyderabad
country: India
facility: N01235 3004
city: Lucknow
country: India
facility: N01235 3001
city: Madurai
country: India
facility: N01235 3009
city: Mumbai
country: India
facility: N01235 3002
city: Mumbai
country: India
facility: N01235 3007
city: Visakhapatnam
country: India
facility: N01235 3011
city: Aguascalientes
country: Mexico
facility: N01235 4006
city: Distrio Federal
country: Mexico
facility: N01235 4003
city: Guadalajara
country: Mexico
facility: N01235 4001
city: Puebla
country: Mexico
facility: N01235 4005
city: Moscow
country: Russian Federation
facility: N01235 5001
city: Moscow
country: Russian Federation
facility: N01235 5002
city: Moscow
country: Russian Federation
facility: N01235 5003
city: Moscow
country: Russian Federation
facility: N01235 5005
city: Moscow
country: Russian Federation
facility: N01235 5006
city: Moscow
country: Russian Federation
facility: N01235 5007
city: Saint Petersburg
country: Russian Federation
facility: N01235 5004
city: Saint Petersburg
country: Russian Federation
facility: N01235 5009
city: Smolensk
country: Russian Federation
facility: N01235 5008
city: Cape Town
country: South Africa
facility: N01235 6002
city: Umhlanga
country: South Africa
facility: N01235 6003
city: Kharkov
country: Ukraine
facility: N01235 7001
city: Kharkov
country: Ukraine
facility: N01235 7004
city: Lviv
country: Ukraine
facility: N01235 7005
city: Odessa
country: Ukraine
facility: N01235 7002
city: Poltava
country: Ukraine
facility: N01235 7003
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.
citation: Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.