Clinical trial NCT00615615: Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures
Official title: Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 216
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.


Eligibility criteria: Inclusion Criteria:

* diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was \>= 6 months before the Selection Visit
* epilepsy was classifiable according to the ILAE Classification
* \>= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have \>= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
* unsatisfactory current AED treatment in terms of efficacy and/or safety
* stable AED treatment consisting of no more than two AEDs

Exclusion Criteria:

* treatable seizure etiology
* epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
* history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
* history of or the presence of pseudo seizures
* current diagnosis of Lennox-Gastaut syndrome

Primary outcomes:
measure: Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period
timeFrame: During the 14-weeks Treatment period (Week 8 to Week 22)
Secondary outcomes:
measure: 50% responder rate in seizure frequency per week during the Treatment Period
timeFrame: During the 14-weeks Treatment period (Week 8 to Week 22)
measure: Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period
timeFrame: From Baseline to the 14-weeks Treatment period
measure: Change from baseline in the average duration of seizure free intervals
timeFrame: From Baseline to the 14-weeks Treatment period
measure: Number of seizure free days during the Treatment Period
timeFrame: During the 14-weeks Treatment period (Week 8 to Week 22)
measure: Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period
timeFrame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
measure: Absolute change from baseline in partial onset seizure frequency per week during the Titration Period
timeFrame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
measure: Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period
timeFrame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
measure: Percent change from baseline in partial onset seizure frequency per week during the Treatment Period
timeFrame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
measure: Percent change from baseline in partial onset seizure frequency per week during the Titration Period
timeFrame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
measure: Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period
timeFrame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
measure: Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period
timeFrame: Beginning of the Evaluation Period (Week 14)
measure: Partial onset seizure frequency per week during the Titration Period
timeFrame: During the 6-weeks Titration period (Week 8 to Week 14)
measure: Partial onset seizure frequency per week during the Evaluation Period
timeFrame: During the 6-weeks Evaluation period (Week 8 to Week 14)
measure: Total seizure frequency per week (Types I + II + III) during the Treatment Period
timeFrame: During the 14-weeks Treatment period (Week 8 to Week 22)
measure: Total seizure frequency per week (Types I + II + III) during the Titration Period
timeFrame: During the 6-weeks Titration period (Week 8 to Week 14)
measure: Total seizure frequency per week (Types I + II + III) during the Evaluation Period
timeFrame: During the 6-weeks Evaluation period (Week 8 to Week 14)
Other outcomes:
Locations:
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ, Lu Z; N159 Study Group. Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology. 2006 Jun 13;66(11):1654-60. doi: 10.1212/01.wnl.0000217916.00225.3a. Epub 2006 Apr 26.
citation: Jensen FE, Bourgeois BF. Randomized trial supports use of levetiracetam adjunctive therapy to treat partial seizures in children. Nat Clin Pract Neurol. 2006 Nov;2(11):596-7. doi: 10.1038/ncpneuro0325. No abstract available.
citation: Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3.