A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures. - Pediatric Exclusivity Long-term Follow-up

Phase 1

Conditions: Epilepsy - Refractory Partial Onset Seizures
MedDRA version: 8.1 Level: LLT Classification code 10061334 Term: Partial seizures

Registration Number: EUCTR2004-000200-40-GB

Lead Sponsor: CB S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 255

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:
• Patient’s parent(s)/legally authorized representative(s) must have consented for the patient to participate in a previous levetiracetam pediatric trial (N01009). 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 study N01009, may be considered to enter this study. Visit 1 will occur on the same day as the screen failure.
• Patients not entering from study N01009 must be 4 to 16 years of age, inclusive.
• The patient’s 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 enrolling directly into N01148 must have a confirmed diagnosis of epilepsy with partial onset seizures, whether or not secondarily generalized for a minimum of six months prior to the Screening Visit.
• 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.
• 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. No additions of new AEDs or deletions of previous AEDs is allowed for at least two weeks prior to the Screening Visit for patients enrolling directly into N01148.
• Patient not entering from study N01009 must have had at least 1 partial onset seizures during the four weeks prior to the Screening Visit.
• 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.
• Patients 4 to 16 years of age, inclusive directly enrolling must have an Intelligence Quotient (IQ) of at least 65 at the Screening Visit.
• The patient and patient's parent(s) or legally authorized representative(s) must be fluent in English.
• For patients enrolling directly into N01148 (4 to 16 years of age, inclusive), 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 the Screening Visit.
• The patient’s epilepsies should be classifiable according to the Proposal for Revised Classification of Epilepsies and Epileptic Syndromes” and his/her seizures should be classifiable according to the Proposal for Revised Clinical and Electroencephalographic Classification of Epileptic Seizures”.
• If enrolling from N01009 and if epile

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.
• Patients enrolling directly into N01148 (4 to 16 years of age, inclusive), must not have had previous treatment with levetiracetam unless, in the opinion of the investigator, the patient’s previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of levetiracetam was confounded by concomitant medication.
• 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 or of the Screening Visit for patients 4 to 16 years of age, inclusive, enrolling directly into N01148.
• 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 has a current psychiatric diagnosis of severe Attention Deficit Hyperactivity Disorder (ADHD), severe behavior disorder or severe learning disorder.
• Patient is receiving phenobarbital or primidone on a routine or chronic basis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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