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

Phase 1

Conditions: Epilepsy - Refractory Partial Onset Seizures
MedDRA version: 7.0Level: LLTClassification code 10061334

Registration Number: EUCTR2004-000200-40-HU

Lead Sponsor: CB S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

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:
• 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

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.

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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