Back to resultsA Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
Primary Purpose
Epilepsy, Generalized Tonic-clonic Seizures
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Epilepsy, Generalized tonic-clonic seizures
Eligibility Criteria
Inclusion Criteria:
- An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
- A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period
Exclusion Criteria:
- Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
- Diagnosis of Lennox-Gastaut Syndrome
- Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
- A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Sites / Locations
- 191
- 184
- 309
- 107
- 303
- 108
- 302
- 306
- 136
- 305
- 190
- 125
- 301
- 116
- 109
- 308
- 119
- 117
- 304
- 103
- 138
- 307
- 139
- 135
- 193
- 310
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levetiracetam
Arm Description
Twice daily (morning and evening) orally
Outcomes
Primary Outcome Measures
The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)
The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.
The percent change from Baseline = (B - T)/B x 100
The seizure frequency per week was calculated using the following formula:
Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7
Secondary Outcome Measures
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.
The percent change from Baseline = (B - E)/B x 100
The seizure frequency per week was calculated using the following formula:
Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7
Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.
Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.
Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01292837
Brief Title
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
Official Title
An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 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
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Generalized Tonic-clonic Seizures
Keywords
Levetiracetam, Epilepsy, Generalized tonic-clonic 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
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Twice daily (morning and evening) orally
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra, E Keppra
Intervention Description
The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
Primary Outcome Measure Information:
Title
The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)
Description
The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.
The percent change from Baseline = (B - T)/B x 100
The seizure frequency per week was calculated using the following formula:
Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7
Time Frame
From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
Secondary Outcome Measure Information:
Title
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
Description
The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.
The percent change from Baseline = (B - E)/B x 100
The seizure frequency per week was calculated using the following formula:
Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7
Time Frame
From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
Title
Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
Description
The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.
Time Frame
From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
Title
Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
Description
The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.
Time Frame
From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
Title
Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
Description
A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.
Time Frame
Treatment Period (Week 0 to Week 24)
Title
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
Description
A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.
Time Frame
Evaluation Period (Week 4 to Week 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period
Exclusion Criteria:
Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
Diagnosis of Lennox-Gastaut Syndrome
Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
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
191
City
Akita
Country
Japan
Facility Name
184
City
Bunkyo
Country
Japan
Facility Name
309
City
Bunkyo
Country
Japan
Facility Name
107
City
Gifu
Country
Japan
Facility Name
303
City
Hiroshima
Country
Japan
Facility Name
108
City
Kobe
Country
Japan
Facility Name
302
City
Kodaira
Country
Japan
Facility Name
306
City
Koshi
Country
Japan
Facility Name
136
City
Moriyama
Country
Japan
Facility Name
305
City
Nagoya
Country
Japan
Facility Name
190
City
Nerima
Country
Japan
Facility Name
125
City
Neyagawa
Country
Japan
Facility Name
301
City
Niigata
Country
Japan
Facility Name
116
City
Ohmura
Country
Japan
Facility Name
109
City
Okayama
Country
Japan
Facility Name
308
City
Onojo
Country
Japan
Facility Name
119
City
Saitama
Country
Japan
Facility Name
117
City
Sapporo
Country
Japan
Facility Name
304
City
Sapporo
Country
Japan
Facility Name
103
City
Sendai
Country
Japan
Facility Name
138
City
Shimotsuke
Country
Japan
Facility Name
307
City
Shizuoka
Country
Japan
Facility Name
139
City
Takatsuki
Country
Japan
Facility Name
135
City
Tsu
Country
Japan
Facility Name
193
City
Yokohama
Country
Japan
Facility Name
310
City
Yufu
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA safety Alerts and Recalls
Learn more about this trial
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
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