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

NCT ID: NCT01398956

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Epilepsy; Generalized Tonic-clonic Seizures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

Twice daily (morning and evening) orally

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

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

Interventions

Levetiracetam

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

Intervention Type: DRUG

Other Intervention Names

Keppra, E Keppra

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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

152

Fujisawa, , Japan

112

Fukuoka, , Japan

113

Fukuoka, , Japan

165

Fukuoka, , Japan

166

Fukuoka, , Japan

187

Fukushima, , Japan

107

Gifu, , Japan

162

Himeji, , Japan

110

Hiroshima, , Japan

117

Hokkaido, , Japan

130

Hokkaido, , Japan

176

Hokkaido, , Japan

143

Kagoshima, , Japan

156

Kagoshima, , Japan

120

Kodaira, , Japan

105

Kokubunji, , Japan

306

Kōshi, , Japan

172

Miyazaki, , Japan

179

Miyazaki, , Japan

305

Nagoya, , Japan

106

Niigata, , Japan

153

Niigata, , Japan

109

Okayama, , Japan

174

Osaka, , Japan

119

Saitama, , Japan

147

Sakai, , Japan

194

Sakai, , Japan

304

Sapporo, , Japan

138

Tochigi, , Japan

184

Tokyo, , Japan

190

Tokyo, , Japan

111

Ube, , Japan

Countries

Japan

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

N01361

Identifier Type: -

Identifier Source: org_study_id