Epilepsy - Refractory Partial Onset Seizures MedDRA version: 7.0 Level: LLT Classification code 10061334
Conditions
Interventions
Trade Name: Keppra
Product Name: Levetiracetam
Product Code: ucbL059
Pharmaceutical Form: Oral solution
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Current Sponsor code: ucb L059
Other
Sponsors
UCB Pharma S.A.
UCB Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Before any study procedures are initiated for any patient in this study, an IRB/IEC approved written informed consent form will be properly executed and documented. To be eligible to participate in this study, the following criteria must be met: • Patients parent(s)/legally authorized representative(s) must have consented to participate in a previous levetiracetam pediatric trial (N01009 or N01103). The last visit of the previous levetiracetam study should occur on the same day as the 1st visit of this study. Patients having been screened, but not eligible for one of the 2 above mentioned studies, may be considered to enter this study. Visit 1 will occur on the same day as the screen failure. • The patients parent(s)/legally authorized representative(s) must give consent and sign and date the IRB/IEC approved written informed consent form for N01148, if applicable, the patient will sign an assent. • Patient must have epilepsy with partial onset seizures. • Be a patient for whom the treatment of levetiracetam would be of potential benefit. • Be a male, or a non-pregnant, non-nursing female. Females of childbearing potential must be using a medically acceptable method of contraception or must agree to abstain from sexual contact. Abstinence must be discussed with UCB or designee on a case by case basis. Females of childbearing potential will have pregnancy tests performed at each scheduled visit during the course of the study. • If the patient was a screen failure in the previous study, the patient must be between 1 month and 16 years of age, inclusive. • Patient may have Vagus Nerve Stimulation (VNS), the settings should be stabilized for at least 2 months prior to Visit 1. Activated VNS must be counted as one of the two AEDs. • Patient must be on a stable regimen of one or a maximum of two other AEDs. • If the patient was a screen failure in the previous study, the patient must have had at least 2 partial onset seizures during the four weeks prior to Visit 1. • Patient and/or their parent(s)/legally authorized representative(s) must be able to cooperate with the Investigator and study personnel involved in carrying out the study. • If enrolling from N01103, the patient must have an Intelligence Quotient (IQ) of at least 70 as assessed during N01103 or at Visit 1 of N01148. • If enrolling from N01103, the patient and patient's parent(s) or legally authorized representative(s) must be fluent in English. • If enrolling from N01103 and if epilepsy surgery has been performed, then the patient should have a documented failed epilepsy surgery outcome of greater than 6 months prior to Visit 1. • If enrolling from N01009 and if epilepsy surgery has been performed, then the patient should have a documented failed epilepsy surgery outcome of at least 4 weeks prior to Visit 1. 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: Patients must be excluded if they meet any of the following criteria: • Participating in any other clinical trial of another investigational drug or device during this study. • Have a history of poor compliance with visit schedule or medication intake. • Are on a ketogenic diet (during the course of this study). • Have seizures too close together to accurately count (i.e., the patient?s seizures must be countable). • Have clinically significant deviations from reference range values for laboratory parameters as determined by the investigator on the blood sample of the last visit of the previous study. • Have any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the investigator) such as, but not limited to: cardiac disease, liver disease, renal disease, or psychiatric illness. • Patient has a treatable seizure etiology other than epilepsy (i.e., febrile seizures). • Patient has a history of status epilepticus, which required hospitalization during one month prior to Visit 1, except for status epilepticus occurring during the first 10 days of life. • Patient has a current diagnosis of Lennox-Gastaut Syndrome. • Patient has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen and Landau-Kleffner diseases. • Patient has a history of an allergy to pyrrolidine derivatives or a history of multiple drug allergies. • Patient is known to have a terminal illness. • Patient has any disorder or condition that may interfere with the absorption, distribution, metabolism, or excretion of medications. • Patient has a history of or presence of pseudoseizures. • Patient has any medical condition that might interfere with the subject™s study participation (i.e., serious infection, scheduled elective surgery, etc). • Patient enrolling from N01103 has a current psychiatric diagnosis of severe Attention Deficit Hyperactivity Disorder (ADHD), severe behavior disorder or severe learning disorder. • Patient enrolling from N01103 receiving phenobarbital or primidone on a routine or chronic basis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to obtain long-term descriptive safety and efficacy data in pediatric epileptic patients with partial onset seizures receiving long-term treatment with levetiracetam at individualized doses. This study in conjunction with Study N157 (UCBs other long-term, follow-up pediatric study) will be used to fulfil the requirement from the FDA written request to determine the long-term safety of levetiracetam as adjunctivetherapy in the treatment of partial onset seizures in pediatric patients.;Secondary Objective: • To allow pediatric patients with partial onset seizures whose parent(s) or legally authorized representative(s) gave consent to participate in a previous levetiracetam pediatric exclusivity trial (N01009 or N01103) the opportunity to receive open-label levetiracetam treatment. • To continue to study the potential cognitive and behavioral effects of levetiracetam in children. • To ensure the safety of study participants by providing standardized follow-up.;Primary end point(s): Primary Efficacy Variables • Percentage change of partial (types I) seizure frequency per week from baseline over time during treatment period. The treatment period includes Titration and Maintenance Phases. Seizure frequency per week = 7 x total number of seizures within the interval/ Number of days in the interval Secondary Efficacy Variables • Percentage change of total (types I, II, III) seizure frequency per week from baseline overtime during treatment period. • Total and partial seizure frequency per week over time during treatment period. • Change from baseline of partial and total seizure frequency per week over time during treatment period. • Responder rate during treatment period • Maximum seizure-free interval during treatment period • Continuously seizure free during study • Seizure types during treatment period including types: I, II, III and IV • Global Evaluation Scales Safety Variables Safety assessments wi | — |
Countries
Belgium, Czech Republic, Hungary, Italy, United Kingdom
Outcome results
None listed