Partial Seizures
Conditions
Interventions
Trade Name: E Keppra® for I.V. infusion 500 mg
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Other descriptive name: Levetiracetam
Concentration
Sponsors
UCB Japan Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject must have a diagnosis of epilepsy with partial onset seizures whether or not secondarily generalized - Male or female from 1 month to =3.0 kg - Subject may have Vagal Nerve Stimulation (VNS) which has been implanted for at least 6 months prior to Visit 1; the settings must be stable for at least 2 months prior to Visit 1. Activated VNS must be counted as 1 of the 2 AEDs - Subject must have experienced at least 2 observable partial seizures, with or without secondary generalization during each 7-day period during the 2 weeks prior to Visit 1. This time period (the 2 weeks prior to Visit 1) will be referred to as the Retrospective Baseline Period. This seizure information (including type, frequency, and date) must have been recorded on a daily record card (DRC) in order to be acceptable - If epilepsy surgery has been performed prior to study entry, subjects must have a documented failed epilepsy surgery outcome at least 4 weeks prior to Visit 1 - The use of intermittent benzodiazepines, phenobarbitals, and phenytoins is allowed as long as the frequency is not greater than 1 single administration per week for at least 2 weeks prior to Visit 1 and throughout study participation. If benzodiazepines are used more than once a week, they must be considered as 1 of the AEDs Are the trial subjects under 18? yes Number of subjects for this age range: 38 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Subject has been taking any medication (other than their concomitant AEDs) that influences the central nervous system (CNS) for which they had not been on a stable regimen for at least 1 month prior to Visit 1 - Subject is taking any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant AEDs or levetiracetam (LEV) during the course of the study - Subject has received any investigational medication or device within 30 days prior to Visit 1 - Subject has taken LEV prior to the study - Subjects using felbamate who have presented with clinically significant abnormalities and/or hepatic function during felbamate treatment, and subjects who are taking felbamate ULN total bilirubin (=1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirm the efficacy of levetiracetam (LEV) in reducing seizure frequency in the First Period compared to historical control as adjunctive treatment in pediatric epilepsy subjects aged 1 month to <4 years with partial seizures;Secondary Objective: - Evaluate the safety and tolerability of LEV in the First Period - Evaluate the efficacy of LEV in reducing seizure frequency in the First Period compared to historical control as monotherapy - Evaluate long-term safety and tolerability of LEV in the combined First and Second Periods in pediatric epilepsy subjects aged 1 month to <4 years with partial seizures receiving long-term treatment with LEV at individualized doses - Evaluate the efficacy of LEV in the combined First and Second Periods as monotherapy or adjunctive treatment - Characterize pharmacokinetics (PK) of LEV in the First and Second Period;Primary end point(s): 1. Percent change in partial seizure frequency per week from Baseline to Visit 6;Timepoint(s) of evaluation of this end point: 1. From Baseline (Week 0) to Visit 6 (up to Week 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percent change in partial seizure frequency per week from Baseline to Visit 4 2. Percent change in partial seizure frequency per week from Baseline to Visit 5 3. Percent change in partial seizure frequency per week on adjunctive therapy 4. Percent change in partial seizure frequency per week grouped into 6 categories on adjunctive therapy 5. Percent change in partial seizure frequency per week on monotherapy 6. Percent change in partial seizure frequency per week grouped into 6 categories on monotherapy 7. Incidence of treatment-emergent adverse events (TEAEs) during the First Period 8. Incidence of treatment-emergent serious adverse events (SAEs) during the First Period 9. Incidence of TEAEs leading to discontinuation from study medication during the First Period 10. Incidence of TEAEs during the Combined First and Second Period 11. Incidence of treatment-emergent SAEs during the Combined First and Second Period 12. Incidence of TEAEs leading to discontinuation from study medication during the Combined First and Second Period;Timepoint(s) of evaluation of this end point: 1. From Baseline (Week 0) to Visit 4 (up to Week 2) 2. From Baseline (Week 0) to Visit 5 (up to Week 4) 3.; 4.; 5; 6. From Baseline (Week 0) for each Visit (up to Week 312) 7.; 8.; 9. From Baseline (Week 0) to Visit 6 (up to Week 6) 10.; 11.; 12. From Baseline (Week 0) to the End of Safety Follow-up (up to Week 314) | — |
Countries
Japan
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed