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

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Generalized Tonic-clonic Seizures
• Intervention / Treatment: Drug: Levetiracetam

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fujisawa, Japan
    • 152
  • Fukuoka, Japan
    • 112
  • Fukuoka, Japan
    • 113
  • Fukuoka, Japan
    • 166
  • Fukuoka, Japan
    • 165
  • Fukushima, Japan
    • 187
  • Gifu, Japan
    • 107
  • Himeji, Japan
    • 162
  • Hiroshima, Japan
    • 110
  • Hokkaido, Japan
    • 117
  • Hokkaido, Japan
    • 130
  • Hokkaido, Japan
    • 176
  • Kagoshima, Japan
    • 143
  • Kagoshima, Japan
    • 156
  • Kodaira, Japan
    • 120
  • Kokubunji, Japan
    • 105
  • Koshi, Japan
    • 306
  • Miyazaki, Japan
    • 179
  • Miyazaki, Japan
    • 172
  • Nagoya, Japan
    • 305
  • Niigata, Japan
    • 106
  • Niigata, Japan
    • 153
  • Okayama, Japan
    • 109
  • Osaka, Japan
    • 174
  • Saitama, Japan
    • 119
  • Sakai, Japan
    • 147
  • Sakai, Japan
    • 194
  • Sapporo, Japan
    • 304
  • Tochigi, Japan
    • 138
  • Tokyo, Japan
    • 184
  • Tokyo, Japan
    • 190
  • Ube, Japan
    • 111

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Keppra, E Keppra

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the Treatment Period (up to 4.8 years)
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.	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 21, 2011

Study Record Updates

• Last Update Posted (Actual): August 15, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; Levetiracetam; Generalized tonic-clonic seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01361