Epilepsy - Refractory Partial Onset Seizures MedDRA version: 7.0 Level: LLT Classification code 10061334
Conditions
Interventions
Trade Name: Keppra
Product Name: Levetiracetam
Product Code: ucb L059
Pharmaceutical Form: Oral solution
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Current Sponsor code: ucb L059
Othe
Sponsors
UCB Pharma S.A.
UCB Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Before any study procedures are initiated for any subject in this study, an IRB/IEC approved written informed consent form will be properly executed and documented. To be eligible to participate in the study, a subject must meet each of the following criteria. • The subject’s parent(s) or legally authorized representative(s) must give consent and sign and date the IRB/IEC approved written informed consent form. • Subject must have a diagnosis of epilepsy with refractory partial onset seizures (i.e., seizures of focal onset), whether or not secondarily generalized. • Subject must be male or female from 1 month to less than 4 years of age. • Must be a subject for whom the Investigator believes that past or current anti-epileptic drug (AED) treatment is unsatisfactory in terms of efficacy and/or safety. • Must be a subject for whom alternative treatment with levetiracetam may be of benefit. • Subject must be on a stable regimen of one or a maximum of two other AEDs for the Selection and Evaluation periods of the study. • Minor adjustments to the dose of current AEDs are allowed only prior to Day -8. • Subject has no additions of new AEDs or deletions of current AEDs that have been observed for at least 2 weeks prior to Day -8. • Subject may have Vagus Nerve Stimulation (VNS) which has been implanted for at least 6 months prior to Day -8; the settings must be stable for at least 2 months prior to Day -8. Activated VNS must be counted as one of the two AEDs. • Subject must have experienced at least two partial onset seizures (i.e., seizures of focal onset), with or without secondary generalization during each 7-day period during the 2 weeks prior to Day -8. • Subjects 1 month to less than 6 months of age must experience at least two, partial onset seizures (i.e., seizures of focal onset), whether or not secondarily generalized during the 48-hour video-EEG performed prior to randomization on Day 1. These seizures do not need to be accompanied by a corresponding clinical event. • Subjects 6 months to less than 1 year of age, subjects 1 year to less than 2 years of age and subjects 2 years to less than 4 years of age must experience at least two partial onset seizures (i.e., seizures of focal onset), whether or not secondarily generalized, during the 48-hour video-EEG performed prior to randomization on Day 1. These seizures must be accompanied by a corresponding clinical event as noted on either video or as reported by a qualified observer, such as a medical doctor or a nurse with significant neurology training and experience. • If epilepsy surgery has been performed prior to study entry, then the subjects must have a documented failed epilepsy surgery outcome at least 4 weeks prior to Day -8. • The use of intermittent benzodiazepines is allowed as long as the frequency is not greater than one single administration per week for at least 2 weeks prior to Day -8 and throughout study participation. • If benzodiazepines are used more than once a week, they must be considered as one of the AEDs. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must be excluded if they meet any of the following criteria: • Subject is taking any medication (other than their concomitant AED(s)) that influences the central nervous system (CNS) for which they have not been on a stable regimen for at least 1 month prior to Day -8. • Subject is taking any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant AEDs or levetiracetam during the course of the study. • Subject has received any investigational medication or device within thirty (30) days prior to Day -8. • Subject has taken levetiracetam prior to the study. • Subjects using felbamate who have presented with clinically significant abnormalities with WBC’s, RBC’s, platelets, and/or hepatic function during felbamate treatment, and subjects who are taking felbamate less than one year from the date of Day -8. • Subject has a treatable seizure etiology, (i.e., febrile seizures). • Subject has a history of status epilepticus requiring hospitalization during the 1 month prior to Day -8, except for status epilepticus occurring during the first 10 days of life. • Subject has a current diagnosis of Lennox-Gastaut syndrome. • Subject is on a ketogenic diet (currently or within 30 days prior to Day -8). • Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen and Landau-Kleffner diseases. • Subject has clinically significant deviations from reference range values for renal function or any of the other laboratory parameters required for this study, as determined by the Investigator. • Subject has any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator). • Subject has an allergy to pyrrolidine derivatives or a history of multiple drug allergies. • Subject is known to have a terminal illness. • Subject has a disorder or condition that may interfere with the absorption, distribution, metabolism, or excretion of medications. • Subject has a history of or presence of pseudoseizures. • Subject has any medical condition that might interfere with the subject’s study participation (i.e., serious infection, scheduled elective surgery, severe scalp eczema, etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of levetiracetam (LEV) used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with refractory partial onset seizures.;Secondary Objective: Not Applicable;Primary end point(s): The primary efficacy analyses will be based on mITT and PP populations. The primary efficacy variable, Responder Rate, for total partial onset seizures for subjects in all age groups is defined as the number of subjects with a = 50% reduction in their average daily frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to the 48-hour Selection video-EEG. Safety parameters will be: physical and neurological examinations, adverse events, vital signs, and laboratory tests, including blood chemistry, levetiracetam (LEV) levels, and hematology. | — |
Countries
Belgium, Czech Republic, Hungary, Italy, United Kingdom
Outcome results
None listed