Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

NCT00615615 | Completed Phase 3

• 1 other identifier: N159
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Keywords

Levetiracetam; Keppra

Outcome Measures

Primary Outcomes (1)

• Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period

  Calculated as 7-day partial onset seizure frequency.

  During the 14-weeks Treatment period (Week 8 to Week 22)

Secondary Outcomes (16)

• 50% responder rate in seizure frequency per week during the Treatment Period

  During the 14-weeks Treatment period (Week 8 to Week 22)

• Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period

  From Baseline to the 14-weeks Treatment period

• Change from baseline in the average duration of seizure free intervals

  From Baseline to the 14-weeks Treatment period

• Number of seizure free days during the Treatment Period

  During the 14-weeks Treatment period (Week 8 to Week 22)

• Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period

  Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)

Study Arms (2)

Levetiracetam (LEV)

EXPERIMENTAL

LEV dose was titrated to a level of 60 mg/kg/day. The initial dose level was 20 mg/kg/day for the first two weeks, followed by a dose level of 40 mg/kg/day for two weeks. If lower doses were well tolerated, the LEV dose was increased to a dose level of 60 mg/kg/day for the remaining 10 weeks. The dose level could be reduced to 40 mg/kg/day if the patient did not tolerate LEV at a dose level of 60 mg/kg/day.

Drug: Levetiracetam

Placebo

PLACEBO COMPARATOR

Subjects received Placebo matching to LEV treatment.

Drug: Placebo

Interventions

Levetiracetam DRUG

* high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg * low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less

Levetiracetam (LEV)

Placebo DRUG

Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy

Placebo

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Related Publications (3)

• 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.

  PMID: 16641323 BACKGROUND

• 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.

  PMID: 17057745 BACKGROUND

• 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.

  PMID: 34033237 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2008
• First Posted: February 14, 2008
• Study Start: September 1, 1999
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: July 30, 2020

Record last verified: 2020-07