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An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects 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
UCB Pharma
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 seizures

Eligibility Criteria

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

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

Sites / Locations

  • 152
  • 112
  • 113
  • 165
  • 166
  • 187
  • 107
  • 162
  • 110
  • 117
  • 130
  • 176
  • 143
  • 156
  • 120
  • 105
  • 306
  • 172
  • 179
  • 305
  • 106
  • 153
  • 109
  • 174
  • 119
  • 147
  • 194
  • 304
  • 138
  • 184
  • 190
  • 111

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levetiracetam

Arm Description

Twice daily (morning and evening) orally

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events During the Entire Study Period

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 13, 2011
Last Updated
July 6, 2017
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01398956
Brief Title
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Official Title
An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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
44 (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
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
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events During the Entire Study Period
Time Frame
Through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
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).
Description
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)
Title
The Incidence of Adverse Drug Reactions During the Entire Study Period
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
152
City
Fujisawa
Country
Japan
Facility Name
112
City
Fukuoka
Country
Japan
Facility Name
113
City
Fukuoka
Country
Japan
Facility Name
165
City
Fukuoka
Country
Japan
Facility Name
166
City
Fukuoka
Country
Japan
Facility Name
187
City
Fukushima
Country
Japan
Facility Name
107
City
Gifu
Country
Japan
Facility Name
162
City
Himeji
Country
Japan
Facility Name
110
City
Hiroshima
Country
Japan
Facility Name
117
City
Hokkaido
Country
Japan
Facility Name
130
City
Hokkaido
Country
Japan
Facility Name
176
City
Hokkaido
Country
Japan
Facility Name
143
City
Kagoshima
Country
Japan
Facility Name
156
City
Kagoshima
Country
Japan
Facility Name
120
City
Kodaira
Country
Japan
Facility Name
105
City
Kokubunji
Country
Japan
Facility Name
306
City
Koshi
Country
Japan
Facility Name
172
City
Miyazaki
Country
Japan
Facility Name
179
City
Miyazaki
Country
Japan
Facility Name
305
City
Nagoya
Country
Japan
Facility Name
106
City
Niigata
Country
Japan
Facility Name
153
City
Niigata
Country
Japan
Facility Name
109
City
Okayama
Country
Japan
Facility Name
174
City
Osaka
Country
Japan
Facility Name
119
City
Saitama
Country
Japan
Facility Name
147
City
Sakai
Country
Japan
Facility Name
194
City
Sakai
Country
Japan
Facility Name
304
City
Sapporo
Country
Japan
Facility Name
138
City
Tochigi
Country
Japan
Facility Name
184
City
Tokyo
Country
Japan
Facility Name
190
City
Tokyo
Country
Japan
Facility Name
111
City
Ube
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

An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

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