A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01292837
First received: February 8, 2011
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).


Condition Intervention Phase
Epilepsy
Generalized Tonic-clonic Seizures
Drug: Levetiracetam
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Anti-epileptic Drugs (AEDs)

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) [ Time Frame: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) ] [ Designated as safety issue: No ]

    The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.

    The percent change from Baseline = (B - T)/B x 100

    The seizure frequency per week was calculated using the following formula:

    Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7



Secondary Outcome Measures:
  • The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period [ Time Frame: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) ] [ Designated as safety issue: No ]

    The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.

    The percent change from Baseline = (B - E)/B x 100

    The seizure frequency per week was calculated using the following formula:

    Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7


  • Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period [ Time Frame: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) ] [ Designated as safety issue: No ]
    The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.

  • Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period [ Time Frame: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) ] [ Designated as safety issue: No ]
    The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.

  • Generalized Tonic-clonic Seizure Freedom Over the Treatment Period [ Time Frame: Treatment Period (Week 0 to Week 24) ] [ Designated as safety issue: No ]
    A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.

  • Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period [ Time Frame: Evaluation Period (Week 4 to Week 24) ] [ Designated as safety issue: No ]
    A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.


Enrollment: 13
Study Start Date: February 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Twice daily (morning and evening) orally
Drug: Levetiracetam
The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
Other Names:
  • Keppra
  • E Keppra

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
  • A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period

Exclusion Criteria:

  • Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
  • Diagnosis of Lennox-Gastaut Syndrome
  • Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
  • A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292837

Locations
Japan
191
Akita, Japan
309
Bunkyo, Japan
184
Bunkyo, Japan
107
Gifu, Japan
303
Hiroshima, Japan
108
Kobe, Japan
302
Kodaira, Japan
306
Koshi, Japan
136
Moriyama, Japan
305
Nagoya, Japan
190
Nerima, Japan
125
Neyagawa, Japan
301
Niigata, Japan
116
Ohmura, Japan
109
Okayama, Japan
308
Onojo, Japan
119
Saitama, Japan
304
Sapporo, Japan
117
Sapporo, Japan
103
Sendai, Japan
138
Shimotsuke, Japan
307
Shizuoka, Japan
139
Takatsuki, Japan
135
Tsu, Japan
193
Yokohama, Japan
310
Yufu, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01292837     History of Changes
Other Study ID Numbers: N01363
Study First Received: February 8, 2011
Results First Received: June 3, 2014
Last Updated: August 21, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014