An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

Phase 3

Completed

Conditions: Partial Seizures
Epilepsy

Interventions: Drug: Levetiracetam

Registration Number: NCT01063764

Lead Sponsor: UCB Japan Co. Ltd.

Brief Summary: Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Detailed Description: Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 73

Inclusion Criteria

The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion Criteria

The patient has a treatable seizure etiology
The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
The patient has a history of status Epilepticus during the 3 months prior to Visit 1
The patient has a past and present history of pseudo seizures
The patient has a current diagnosis of Lennox-Gastaut syndrome

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	Open-label, single-arm

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)	During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)	An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.
Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period	From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22	The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as: (B values- T values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.

Secondary Outcome Measures

Name	Time	Method
Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period	10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)	The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Number of Seizure-free Subjects Over the 10-weeks Evaluation Period	10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)	Seizure-free means not having a seizure of type I (Partial seizure). Partial seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)	During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)	An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.
Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period	10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)	50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders. Partial seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period	14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))	The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)	From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)	The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented. Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period	From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)	The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period	14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))	50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders. Partial seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Number of Seizure-free Subjects Over the 14-weeks Treatment Period	14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))	Seizure-free means not having a seizure of type I (Partial seizure). Partial seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.

Trial Locations

Locations (29): 10
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Koushi, Japan
31
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Kurume, Japan
8
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Neyagawa, Japan
1
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Niigata, Japan
25
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Osaka, Japan
16
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Tokyo, Japan
13
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Sendai, Japan
4
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Shizuoka, Japan
20
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Yokohama, Japan
19
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Yokohama, Japan
3
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Kodaira, Japan
5
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Nagoya, Japan
21
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Chuo, Japan
12
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Hakodate, Japan
23
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Kyoto, Japan
28
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Hiroshima, Japan
22
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Hamamatsu, Japan
7
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Izumi, Japan
30
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Koga, Japan
24
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Osaka, Japan
26
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Takatsuki, Japan
17
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Tokyo, Japan
14
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Yamagata, Japan
9
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Kobe, Japan
27
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Okayama, Japan
11
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Sapporo, Japan
15
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Yachiyo, Japan
2
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Nagaoka, Japan
6
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Nagoya, Japan