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

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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:
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

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



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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398956


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)

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01398956     History of Changes
Other Study ID Numbers: N01361
First Posted: July 21, 2011    Key Record Dates
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
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs