Epilepsy MedDRA version: 9.1 Level: LLT Classification code 10015037 Term: Epilepsy
Conditions
Interventions
Trade Name: Keppra ®
Product Name: Levetiracetam
Product Code: L059
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Current Sponso
Sponsors
UCB Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An IRB/IEC approved written informed consent signed and dated by parent(s) or legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors (if applicable, according to age). 2. The subject suffers from epilepsy (except status epilepticus). 3. Male or female between 4 - 16 years of age, inclusive. Females must not be pregnant or nursing. Females of childbearing potential must have a negative pregnancy test at Screening. 4. Body weight at Screening is at least 10 kg. 5. The subject requires a short treatment with levetiracetam IV (i.e., because of subject’s temporary inability to swallow, etc.), whether or not already taking levetiracetam oral tablets or oral solution. 6. If taking levetiracetam oral treatment, dose regimen should have been stable for at least 5 days prior to the first LEV IV infusion. 7. In-patient at least during the LEV IV infusion period. 8. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator. 9. Concomitant AEDs that are enzyme inducers should be stable over the past 4 weeks prior to the first LEV IV infusion. However, a change of dose of concomitant AEDs that are enzymes inducers or introduction of a new AED that is enzymes inducer is for: • One single dose administration: acceptable at any time; • Repeated administration: • accepted if it occurs = 24 hrs prior to the 1st LEV IV infusion • not accepted if it occurs = 72 hrs prior to the 1st LEV IV infusion. • considered on a case by case basis (depending on the AED and its dosage) if it occurs between these 2limits (> 24 hrs and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing females. 2. The subject has difficult venous accessibility. 3. The subject has a history of status epilepticus during the 3 months prior to Screening. 4. The subject has an allergy to pyrrolidone derivatives or a history of multiple drug allergies. 5. The subject has any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator: e.g. cardio-respiratory disorders, bone marrow depression, chronic hepatic disease, severe renal impairment). 6. The subject has any medical condition that might interfere with his/her study participation, i.e., serious infection, etc. 7. The subject has history of suicide attempt or presents with current depressive symptoms, current suicidal ideation and/or behavior. 8. The subject has a terminal illness. 9. The subject presents clinically significant ECG abnormalities according to the Investigator. 10. The subject presents clinically significant abnormal blood pressure and/or heart rate, according to the Investigator. 11. The subject has any clinically significant deviations from reference range values for laboratory parameters as determined by the Investigator taking into account the history of the patient with regard to the lab parameter and the changes related to the current medical condition. 12. The subject received any investigational drug or device within the 30 days prior to Screening. The use of AEDs marketed for adults but not approved for pediatric use is not considered to be “investigational” for the purposes of this study. 13. The subject has ever taken felbamate. 14. The subject is on a ketogenic diet (currently or within 30 days prior to Screening). 15. The subject has been previously allocated/has received a trial treatment in this trial. 16. Investigators’, co-investigators’ or any trial collaborator’s children may not be included as subjects in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of levetiracetam intravenous 15-minutes infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (4 - 16 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.;Secondary Objective: To assess the pharmacokinetics of levetiracetam 15-minutes intravenous infusion, administered every 12 hours, in children with epilepsy in the age range of 4 - 16 years.;Primary end point(s): The intent-to-treat population (ITT) will consist of all subjects who received at least one dose of study medication. The pharmacokinetic per-protocol population (PK - PP) is a subset of the ITT population, consisting of any subject providing at least one valid post-dose concentration result as confirmed during a pre-analysis meeting prior to database lock. Pharmacokinetic Variables: The concentration of levetiracetam (parent compound only) will be determined in plasma and saliva samples. Safety Variables • Adverse Events (including seizure worsening and local tolerability at the site of infusion); • Body weight; • Vital Signs (blood pressure and heart rate); • 12-lead Electrocardiogram (ECG) recordings; • Physical and Neurological Examinations; • Laboratory tests (blood - hematology and biochemistry); • Plasma concentrations of AEDs. | — |
Countries
Belgium, France, Germany
Outcome results
None listed