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

Primary Purpose

Epilepsy, Partial Seizures

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Japan Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Keppra, Levetiracetam, Children, Epilepsy, Partial Seizures

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 21
  • 12
  • 22
  • 28
  • 7
  • 9
  • 3
  • 30
  • 10
  • 31
  • 23
  • 2
  • 5
  • 6
  • 8
  • 1
  • 27
  • 24
  • 25
  • 11
  • 13
  • 4
  • 26
  • 16
  • 17
  • 15
  • 14
  • 19
  • 20

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levetiracetam

Arm Description

Open-label, single-arm

Outcomes

Primary Outcome Measures

Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
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.
Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second 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.

Secondary Outcome Measures

Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
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.
Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
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.
Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period
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.
Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period
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.
Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period
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.
Number of Seizure-free Subjects Over the 14-weeks Treatment Period
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.
Number of Seizure-free Subjects Over the 10-weeks Evaluation Period
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)
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.
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)
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.

Full Information

First Posted
February 1, 2010
Last Updated
February 16, 2015
Sponsor
UCB Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01063764
Brief Title
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Official Title
An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Japan Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial Seizures
Keywords
Keppra, Levetiracetam, Children, Epilepsy, Partial Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Open-label, single-arm
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Primary Outcome Measure Information:
Title
Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
Description
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.
Time Frame
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
Title
Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
Description
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.
Time Frame
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)
Secondary Outcome Measure Information:
Title
Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
Description
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.
Time Frame
From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Title
Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
Description
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.
Time Frame
14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Title
Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period
Description
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.
Time Frame
10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Title
Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period
Description
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.
Time Frame
14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Title
Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period
Description
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.
Time Frame
10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Title
Number of Seizure-free Subjects Over the 14-weeks Treatment Period
Description
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.
Time Frame
14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Title
Number of Seizure-free Subjects Over the 10-weeks Evaluation Period
Description
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.
Time Frame
10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Title
Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)
Description
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.
Time Frame
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)
Title
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)
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
21
City
Chuo
Country
Japan
Facility Name
12
City
Hakodate
Country
Japan
Facility Name
22
City
Hamamatsu
Country
Japan
Facility Name
28
City
Hiroshima
Country
Japan
Facility Name
7
City
Izumi
Country
Japan
Facility Name
9
City
Kobe
Country
Japan
Facility Name
3
City
Kodaira
Country
Japan
Facility Name
30
City
Koga
Country
Japan
Facility Name
10
City
Koushi
Country
Japan
Facility Name
31
City
Kurume
Country
Japan
Facility Name
23
City
Kyoto
Country
Japan
Facility Name
2
City
Nagaoka
Country
Japan
Facility Name
5
City
Nagoya
Country
Japan
Facility Name
6
City
Nagoya
Country
Japan
Facility Name
8
City
Neyagawa
Country
Japan
Facility Name
1
City
Niigata
Country
Japan
Facility Name
27
City
Okayama
Country
Japan
Facility Name
24
City
Osaka
Country
Japan
Facility Name
25
City
Osaka
Country
Japan
Facility Name
11
City
Sapporo
Country
Japan
Facility Name
13
City
Sendai
Country
Japan
Facility Name
4
City
Shizuoka
Country
Japan
Facility Name
26
City
Takatsuki
Country
Japan
Facility Name
16
City
Tokyo
Country
Japan
Facility Name
17
City
Tokyo
Country
Japan
Facility Name
15
City
Yachiyo
Country
Japan
Facility Name
14
City
Yamagata
Country
Japan
Facility Name
19
City
Yokohama
Country
Japan
Facility Name
20
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24018745
Citation
Nakamura H, Osawa M, Yokoyama T, Yoshida K, Suzuki A. [Efficacy and safety of levetiracetam as adjunctive therapy in Japanese children with uncontrolled partial-onset seizures: multicenter and open-label study (N01223), short term evaluation]. Brain Nerve. 2013 Sep;65(9):1083-92. Japanese.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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