Low and High Dose Zonisamide in Children as Monotherapy
NCT ID: NCT01127165
Last Updated: 2012-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
125 participants
INTERVENTIONAL
2006-03-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Zonisamide Low Dose Group
zonisamide low dose group
Initial dose was 2mg/kg/day, increased after 1\~2 weeks to 3\~4mg/kg/day.
Zonisamide High Dose group
zonisamide high dose group
Initial dose was 2mg/kg/day, increased after 2\~4 weeks to 6\~8mg/kg/day.
Interventions
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zonisamide low dose group
Initial dose was 2mg/kg/day, increased after 1\~2 weeks to 3\~4mg/kg/day.
zonisamide high dose group
Initial dose was 2mg/kg/day, increased after 2\~4 weeks to 6\~8mg/kg/day.
Eligibility Criteria
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Inclusion Criteria
2. Patients had at least two seizures for the last 6 months before entry.
3. Patients who had never taken antiepileptic drugs.
4. Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG).
5. Agreement of the guardian is needed.
Exclusion Criteria
2. Patients with serious disorder.
3. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase \[SGOT\]) or (serum glutamic pyruvic transaminase \[SGPT\]) values more than twice the normal values.
4. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values.
5. Hemolytic anemia.
2 Years
15 Years
ALL
No
Sponsors
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Eisai Korea Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jihee Mun
Role: STUDY_DIRECTOR
Medical Department, Eisai Korea Inc.
Locations
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Dongsan Medical Center of Keimyung Univ.
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Inje Univ. Ilsan-Paik Hospital
Seoul, , South Korea
Inje Univ. Sanggye-Paik Hospital
Seoul, , South Korea
Korea Univ. Ansan Hospital
Seoul, , South Korea
Korea Univ. Guro Hospital
Seoul, , South Korea
National Health Insurance Corporation Ilsan Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Soonchunhyang Univ. Cheonan Hospital
Seoul, , South Korea
Soonchunhyang Univ. Hospital
Seoul, , South Korea
Yeungnam University Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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E2090-S082-404
Identifier Type: -
Identifier Source: org_study_id