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A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

Primary Purpose

Epilepsy, Generalized Tonic-Clonic Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levetiracetam
Placebo
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 Levetiracetam, epilepsy, generalized tonic-clonic

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE 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 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 imagining features
  • A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1

Sites / Locations

  • 1
  • 9
  • 12
  • 19
  • 6
  • 10
  • 16
  • 5
  • 18
  • 13
  • 22
  • 14
  • 2
  • 3
  • 17
  • 15
  • 8
  • 7
  • 20
  • 152
  • 112
  • 113
  • 166
  • 187
  • 124
  • 175
  • 162
  • 110
  • 177
  • 165
  • 143
  • 156
  • 176
  • 150
  • 153
  • 105
  • 172
  • 179
  • 186
  • 189
  • 106
  • 158
  • 129
  • 157
  • 174
  • 130
  • 170
  • 147
  • 194
  • 117
  • 131
  • 304
  • 103
  • 168
  • 138
  • 121
  • 120
  • 111

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Levetiracetam

Arm Description

Matching placebo for 28 weeks

Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Outcomes

Primary Outcome Measures

Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)
Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline 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 28-week treatment Period. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline

Secondary Outcome Measures

The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period
Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation 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. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline.
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
A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
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 Evaluation Period
A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.

Full Information

First Posted
October 22, 2010
Last Updated
January 3, 2019
Sponsor
UCB Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01228747
Brief Title
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
Official Title
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (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
The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo for 28 weeks
Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra®
Intervention Description
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral placebo tablets twice daily for 28 weeks
Primary Outcome Measure Information:
Title
Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)
Description
Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline 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 28-week treatment Period. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
Time Frame
From Baseline to Week 28
Secondary Outcome Measure Information:
Title
The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period
Description
Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation 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. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline.
Time Frame
From Baseline to Evaluation Period (Week 12 to Week 28)
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
A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
Time Frame
From Baseline to Week 28
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 Evaluation Period
Description
A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
Time Frame
From Baseline to Evaluation Period (Week 12 to Week 28)
Title
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
Description
A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.
Time Frame
Evaluation Period (Week 12 to Week 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE 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 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 imagining features A history of convulsive or non-convulsive 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
1
City
Beijing
Country
China
Facility Name
9
City
Beijing
Country
China
Facility Name
12
City
Changchun
Country
China
Facility Name
19
City
Chengdu
Country
China
Facility Name
6
City
Chengdu
Country
China
Facility Name
10
City
Chongqing
Country
China
Facility Name
16
City
Guangzhou
Country
China
Facility Name
5
City
Guangzhou
Country
China
Facility Name
18
City
Harbin
Country
China
Facility Name
13
City
Kunming
Country
China
Facility Name
22
City
Nanjing
Country
China
Facility Name
14
City
Qingdao
Country
China
Facility Name
2
City
Shanghai
Country
China
Facility Name
3
City
Shanghai
Country
China
Facility Name
17
City
Shenyang
Country
China
Facility Name
15
City
Taiyuan
Country
China
Facility Name
8
City
Wuhan
Country
China
Facility Name
7
City
Xi'an
Country
China
Facility Name
20
City
Xian
Country
China
Facility Name
152
City
Fujisawa
Country
Japan
Facility Name
112
City
Fukuoka
Country
Japan
Facility Name
113
City
Fukuoka
Country
Japan
Facility Name
166
City
Fukuoka
Country
Japan
Facility Name
187
City
Fukushima
Country
Japan
Facility Name
124
City
Hamamatsu
Country
Japan
Facility Name
175
City
Higashiosaka
Country
Japan
Facility Name
162
City
Himeji
Country
Japan
Facility Name
110
City
Hiroshima
Country
Japan
Facility Name
177
City
Hiroshima
Country
Japan
Facility Name
165
City
Iizuka
Country
Japan
Facility Name
143
City
Kagoshima
Country
Japan
Facility Name
156
City
Kagoshima
Country
Japan
Facility Name
176
City
Kameda
Country
Japan
Facility Name
150
City
Kashihara
Country
Japan
Facility Name
153
City
Kashiwakazi
Country
Japan
Facility Name
105
City
Kokubunji
Country
Japan
Facility Name
172
City
Miyakonojo
Country
Japan
Facility Name
179
City
Miyazaki
Country
Japan
Facility Name
186
City
Miyazaki
Country
Japan
Facility Name
189
City
Nagoya
Country
Japan
Facility Name
106
City
Niigata
Country
Japan
Facility Name
158
City
Okayama
Country
Japan
Facility Name
129
City
Osaka-sayama
Country
Japan
Facility Name
157
City
Osaka
Country
Japan
Facility Name
174
City
Osaka
Country
Japan
Facility Name
130
City
Otaru
Country
Japan
Facility Name
170
City
Saito
Country
Japan
Facility Name
147
City
Sakai
Country
Japan
Facility Name
194
City
Sakai
Country
Japan
Facility Name
117
City
Sapporo
Country
Japan
Facility Name
131
City
Sapporo
Country
Japan
Facility Name
304
City
Sapporo
Country
Japan
Facility Name
103
City
Sendai
Country
Japan
Facility Name
168
City
Shimajiri
Country
Japan
Facility Name
138
City
Shimotsuke
Country
Japan
Facility Name
121
City
Shizuoka
Country
Japan
Facility Name
120
City
Tokyo
Country
Japan
Facility Name
111
City
Ube
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30525116
Citation
Wu L, Yagi K, Hong Z, Liao W, Wang X, Zhou D, Inoue Y, Ohtsuka Y, Sasagawa M, Terada K, Du X, Muramoto Y, Sano T. Adjunctive levetiracetam in the treatment of Chinese and Japanese adults with generalized tonic-clonic seizures: A double-blind, randomized, placebo-controlled trial. Epilepsia Open. 2018 Sep 29;3(4):474-484. doi: 10.1002/epi4.12255. eCollection 2018 Dec.
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

A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

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