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

• ClinicalTrials.gov Identifier: NCT01398956
• Recruitment Status: Completed
• First Posted: July 21, 2011
• Results First Posted: March 9, 2017
• Last Update Posted: August 15, 2017
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy; Generalized Tonic-clonic Seizures	Drug: Levetiracetam	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2011
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Levetiracetam; Twice daily (morning and evening) orally	Drug: 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; Other Name: Keppra, E Keppra

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment Emergent Adverse Events During the Entire Study Period [ Time Frame: Through study completion, an average of 3 years ]

Secondary Outcome Measures :

1. 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). [ Time Frame: 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.

2. The Incidence of Adverse Drug Reactions During the Entire Study Period [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 4 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Japan

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

Koshi, 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

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT01398956
• Other Study ID Numbers: N01361
• First Posted: July 21, 2011
• Results First Posted: March 9, 2017
• Last Update Posted: August 15, 2017
• Last Verified: July 2017

Keywords provided by UCB Pharma:

Levetiracetam; Epilepsy; Generalized tonic-clonic seizures

Additional relevant MeSH terms:

Epilepsy; Seizures; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Levetiracetam; Anticonvulsants; Nootropic Agents