Epilepsy, Generalized Tonic-clonic Seizures
Conditions
Keywords
Levetiracetam, Epilepsy, Generalized tonic-clonic seizures
Brief summary
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.
Interventions
DRUGLevetiracetam
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
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment Emergent Adverse Events During the Entire Study Period | Through study completion, an average of 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | During the Treatment Period (up to 4.8 years) | 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. |
| The Incidence of Adverse Drug Reactions During the Entire Study Period | Through study completion, an average of 3 years | Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug. |
Countries
Japan
Participant flow
Recruitment details
This study started to enroll subjects in Japan in June 2011.
Pre-assignment details
Participant Flow refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
Participants by arm
| Arm | Count |
|---|---|
| Levetiracetam Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | AE, non-serious non-fatal | 4 |
| Overall Study | Subject moved a long distance | 1 |
| Overall Study | Withdrawal by Subject | 4 |
| Overall Study | Withdrawal Criteria No.3 | 1 |
Baseline characteristics
| Characteristic | Levetiracetam |
|---|---|
| Age, Categorical <=18 years | 15 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 Years | 28 Participants |
| Age, Continuous | 26.1 years STANDARD_DEVIATION 13.9 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 44 |
| serious Total, serious adverse events | 13 / 44 |
Outcome results
Primary
Incidence of Treatment Emergent Adverse Events During the Entire Study Period
Time frame: Through study completion, an average of 3 years
Population: The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levetiracetam (SS) | Incidence of Treatment Emergent Adverse Events During the Entire Study Period | 626 Treatment Emergent Adverse Events |
Secondary
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
Population: The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levetiracetam (SS) | The Incidence of Adverse Drug Reactions During the Entire Study Period | 46 Adverse Drug Reactions |
Secondary
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)
Population: The Full Analysis Set (FAS) consisted of all subjects with evaluable baseline and post-baseline values of generalized tonic-clonic (GTC) seizure frequency as the efficacy analysis, excluding those patients who seriously violated Good Clinical Practice (GCP).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levetiracetam (SS) | 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). | -92.07 percent change |