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

Phase 3

Completed

• Conditions: Epilepsy; Generalized Tonic-clonic Seizures
• Interventions: Drug: Levetiracetam

• Registration Number: NCT01398956
• Lead Sponsor: UCB Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-21
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2016-09-29
• Results First Submitted QC: 2017-02-27
• Results First Posted: 2017-03-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	Twice daily (morning and evening) orally

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events During the Entire Study Period	Through study completion, an average of 3 years

Secondary Outcome Measures

Name	Time	Method
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).	During the Treatment Period (up to 4.8 years)	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	Through study completion, an average of 3 years	Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.

Trial Locations

Locations (32)

105; 🇯🇵 Kokubunji, Japan

162; 🇯🇵 Himeji, Japan

110; 🇯🇵 Hiroshima, Japan

143; 🇯🇵 Kagoshima, Japan

172; 🇯🇵 Miyazaki, Japan

112; 🇯🇵 Fukuoka, Japan

306; 🇯🇵 Koshi, Japan

130; 🇯🇵 Hokkaido, Japan

176; 🇯🇵 Hokkaido, Japan

187; 🇯🇵 Fukushima, Japan

117; 🇯🇵 Hokkaido, Japan

120; 🇯🇵 Kodaira, Japan

156; 🇯🇵 Kagoshima, Japan

305; 🇯🇵 Nagoya, Japan

109; 🇯🇵 Okayama, Japan

111; 🇯🇵 Ube, Japan

119; 🇯🇵 Saitama, Japan

179; 🇯🇵 Miyazaki, Japan

194; 🇯🇵 Sakai, Japan

304; 🇯🇵 Sapporo, Japan

138; 🇯🇵 Tochigi, Japan

184; 🇯🇵 Tokyo, Japan

190; 🇯🇵 Tokyo, Japan

152; 🇯🇵 Fujisawa, Japan

113; 🇯🇵 Fukuoka, Japan

107; 🇯🇵 Gifu, Japan

165; 🇯🇵 Fukuoka, Japan

166; 🇯🇵 Fukuoka, Japan

153; 🇯🇵 Niigata, Japan

106; 🇯🇵 Niigata, Japan

174; 🇯🇵 Osaka, Japan

147; 🇯🇵 Sakai, Japan