Epilepsy Generalized Tonic-Clonic Seizures MedDRA version: 19.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: LLT Classification code 10062448 Term: Generalized tonic-clonic seizure System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Keppra 250 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Current Sponsor code: ucb L059
Other descriptive name: Keppra
Concentration
Sponsors
UCB Japan Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy. - The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators Are the trial subjects under 18? yes Number of subjects for this age range: 14 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide the levetiracetam (LEV) treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with LEV by the investigators and who are willing to continuously receive this drug. To evaluate the safety and tolerability of long-term administration of LEV at doses up to 60mg/kg/day or 3000mg/day in subjects with epilepsy in Japan who have completed the N01159 or N01363 or have discontinued the N01159 due to lack of efficacy.;Secondary Objective: To evaluate the efficacy of LEV long-term administration of LEV at doses up to 60mg/kg/day or 3000mg/day in subjects with epilepsy in Japan who have completed N01159 or N01363 or who have discontinued N01159 due to lack of efficacy.;Primary end point(s): Incidence of treatment emergent adverse events during the entire study period.;Timepoint(s) of evaluation of this end point: Evaluation and Withdrawal Periods(up to 3 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - Baseline of feeder study until end of study(up to 3 years) - Evaluation and Withdrawal Periods(up to 3 years);Secondary end point(s): - The percentage reduction in Generalized Tonic-Clonic (GTC) seizure frequency per week over the Evaluation Period from either of the Combined Baseline Periods of the previous studies (N01159 or N01363) - The incidence of adverse drug reactions during the entire study period | — |
Countries
Japan
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed