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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01398956
First Posted: July 21, 2011
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  Purpose
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 Intervention Phase
Epilepsy Generalized Tonic-clonic Seizures Drug: Levetiracetam Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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

Secondary Outcome Measures:
  • 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.


  • 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.


Enrollment: 44
Study Start Date: June 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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)
  More Information

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01398956     History of Changes
Other Study ID Numbers: N01361
First Submitted: July 13, 2011
First Posted: July 21, 2011
Results First Submitted: September 29, 2016
Results First Posted: August 15, 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