An Open Label Study of L059 (levetiracetam) in Japanese epilepsy subjects with Generalized Tonic-clonic Seizures
- Conditions
- EpilepsyGeneralized Tonic-Clonic SeizuresMedDRA version: 19.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0Level: LLTClassification code 10062448Term: Generalized tonic-clonic seizureSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-002879-96-Outside-EU/EEA
- Lead Sponsor
- CB Japan Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 46
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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 Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: - Baseline of feeder study until end of study(up to 3 years)<br>- 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)<br>- The incidence of adverse drug reactions during the entire study period