An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

UCB Pharma44 enrolled

Overview

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy Generalized Tonic-clonic Seizures

Interventions

LevetiracetamDRUG

formulation: tablet or dry syrup strength: 250 mg tablet, 500 mg tablet, dry syrup 50% dosage: Sb ≥16 years and ≥4 and \<16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and \<16 years (\<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day frequency: twice daily

Eligibility

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

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 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

Locations (32)

152

Fujisawa, Japan

112

Fukuoka, Japan

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Events During the Entire Study Period

Time frame: Through study completion, an average of 3 years

Secondary Outcomes

The Percentage Change 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).

Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)\*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period.

Time frame: During the Treatment Period (up to 4.8 years)

The Incidence of Adverse Drug Reactions During the Entire Study Period

Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.

Time frame: Through study completion, an average of 3 years

Data from ClinicalTrials.gov

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