Clinical Trials List
Protocol NumberTOPMATEPY4067
NCT Number(ClinicalTrials.gov Identfier)NCT02201251
2015-05-01 - 2022-07-31
Phase III
Terminated5
ICD-10G40.309
Generalized idiopathic epilepsy and epileptic syndromes, not intractable, without status epilepticus
A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy compared with Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent - Onset Epilepsy.
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Janssen Research & Development, L.L.C.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 洪碧蓮 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yu-Tzu Chang Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chuan-Yu Wang Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 王輝雄 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- WEN-CHIN WENG Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Epilepsy
Objectives
Primary Objective
The primary objective is to evaluate the effects of topiramate monotherapy compared with levetiracetam,
another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy on
pediatric growth and maturation, bone mineralization, and kidney stone formation in children 2 to
15 years of age.
Secondary Objective
Overall safety will be assessed.
Test Drug
Topamax F.C. Tablets 25mg, 50mg, 100mg and Topamax Sprinkle Capsule 25mg
Active Ingredient
topiramate
Dosage Form
F.C. Tablets
Sprinkle Capsule
Sprinkle Capsule
Dosage
100mg
25mg
25mg
Endpoints
PHARMACOKINETIC EVALUATIONS
Blood samples (1 mL per sample) for the determination of plasma topiramate and levetiracetam
concentrations will be obtained during clinic visits according to the Time and Events schedule. If
possible, blood samples for pharmacokinetic (PK) evaluations should be trough samples (ie, taken
immediately before the morning dose) and coincide with samples drawn for clinical laboratory tests.
During each PK assessment, the dosing regimen, dose administered, time and date of dose administration,
time of sample collection, and concomitant medications will be recorded in the case report form.
Pharmacokinetic parameters will not be estimated. Topiramate and levetiracetam plasma concentration
data will be summarized.
SAFETY EVALUATIONS
Safety evaluations will include:
12-lead electrocardiogram (screening only)
Vital signs (including orthostatic vital signs), body weight, and height (all visits except Month 2)
Neurologic and physical examinations (all visits except Month 2)
Physical activity evaluation (screening)
Clinical laboratory tests (screening, Month 1, Month 3, Month 6, Month 9, and Month 12/early
withdrawal)
Pregnancy testing (for girls of childbearing potential; serum at screening only; urine at all other visits)
24-hour urine collection (baseline, Month 6, and Month 12/early withdrawal)
Adverse event monitoring, concomitant medication monitoring (throughout)
Suicidality, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS; all visits except
screening)
DEXA scan (baseline, Month 6, and Month 12/early withdrawal)
Renal ultrasound, biochemical bone markers (screening, Month 6, and Month 12/early withdrawal)
Bone age, as determined by hand/wrist x-ray (baseline and Month 12/early withdrawal)
Tanner staging (baseline, Month 6, and Month 12 or early withdrawal)
Seizure counts recorded by parent/guardian in take-home seizure diary (all visits beginning at
baseline)
Cognitive, developmental, and behavioral assessments, conducted as follows:
Cogstate Battery (2 practice sessions, 1 at screening and 1 at baseline prior to the baseline
assessment; assessed at baseline, Month 6, and Month 12/early withdrawal):
o For subjects 6 to 15 years of age, the Detection Test, Identification Test, One Card
Learning Test, One Back Test, and Groton Maze Learning Test will be administered.
o For cooperative subjects 4 to 5 years of age, the Detection Test and the Identification Test
will be administered.
Language function test (Animal Fluency NEPSY-II (A Developmental NEuroPSYchological
Assessment); 1 practice session at screening; assessed at baseline, Month 6, and Month
12/early withdrawal for subjects 6 to 15 years of age)
Vineland Adaptive Behavior Scale (to be completed by a parent or guardian for subjects 2 to
5 years of age, assessed at baseline, Month 3, Month 6, and Month 12/early withdrawal)
Child Behavior Checklist (CBCL; assessed at baseline, Month 3, Month 6, and
Month 12/early withdrawal) - Parent version (Achenbach System of Empirically Based
Assessment)
o Preschool version – subjects 2 to 5 years of age
o School-age version - subjects 6 to 15 years of age
Note: For subjects who turn 6 years of age during the study, the Vineland Adaptive Behavior
Scale and the preschool version of the CBCL will continue to be administered throughout the
study.
Blood samples (1 mL per sample) for the determination of plasma topiramate and levetiracetam
concentrations will be obtained during clinic visits according to the Time and Events schedule. If
possible, blood samples for pharmacokinetic (PK) evaluations should be trough samples (ie, taken
immediately before the morning dose) and coincide with samples drawn for clinical laboratory tests.
During each PK assessment, the dosing regimen, dose administered, time and date of dose administration,
time of sample collection, and concomitant medications will be recorded in the case report form.
Pharmacokinetic parameters will not be estimated. Topiramate and levetiracetam plasma concentration
data will be summarized.
SAFETY EVALUATIONS
Safety evaluations will include:
12-lead electrocardiogram (screening only)
Vital signs (including orthostatic vital signs), body weight, and height (all visits except Month 2)
Neurologic and physical examinations (all visits except Month 2)
Physical activity evaluation (screening)
Clinical laboratory tests (screening, Month 1, Month 3, Month 6, Month 9, and Month 12/early
withdrawal)
Pregnancy testing (for girls of childbearing potential; serum at screening only; urine at all other visits)
24-hour urine collection (baseline, Month 6, and Month 12/early withdrawal)
Adverse event monitoring, concomitant medication monitoring (throughout)
Suicidality, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS; all visits except
screening)
DEXA scan (baseline, Month 6, and Month 12/early withdrawal)
Renal ultrasound, biochemical bone markers (screening, Month 6, and Month 12/early withdrawal)
Bone age, as determined by hand/wrist x-ray (baseline and Month 12/early withdrawal)
Tanner staging (baseline, Month 6, and Month 12 or early withdrawal)
Seizure counts recorded by parent/guardian in take-home seizure diary (all visits beginning at
baseline)
Cognitive, developmental, and behavioral assessments, conducted as follows:
Cogstate Battery (2 practice sessions, 1 at screening and 1 at baseline prior to the baseline
assessment; assessed at baseline, Month 6, and Month 12/early withdrawal):
o For subjects 6 to 15 years of age, the Detection Test, Identification Test, One Card
Learning Test, One Back Test, and Groton Maze Learning Test will be administered.
o For cooperative subjects 4 to 5 years of age, the Detection Test and the Identification Test
will be administered.
Language function test (Animal Fluency NEPSY-II (A Developmental NEuroPSYchological
Assessment); 1 practice session at screening; assessed at baseline, Month 6, and Month
12/early withdrawal for subjects 6 to 15 years of age)
Vineland Adaptive Behavior Scale (to be completed by a parent or guardian for subjects 2 to
5 years of age, assessed at baseline, Month 3, Month 6, and Month 12/early withdrawal)
Child Behavior Checklist (CBCL; assessed at baseline, Month 3, Month 6, and
Month 12/early withdrawal) - Parent version (Achenbach System of Empirically Based
Assessment)
o Preschool version – subjects 2 to 5 years of age
o School-age version - subjects 6 to 15 years of age
Note: For subjects who turn 6 years of age during the study, the Vineland Adaptive Behavior
Scale and the preschool version of the CBCL will continue to be administered throughout the
study.
Inclution Criteria
Inclusion Criteria:
• Participant with a clinical diagnosis of new-onset or recent-onset epilepsy characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening
• Caregivers (parents or legally acceptable representatives) of the participant must be able to accurately maintain the participant take-home record and seizure diary
• At screening, participant must have weight and height values within the 5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control [CDC])
• Participant must never have been treated for epilepsy (treatment-naïve) or have been treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment
• Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation
• Participant with a clinical diagnosis of new-onset or recent-onset epilepsy characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening
• Caregivers (parents or legally acceptable representatives) of the participant must be able to accurately maintain the participant take-home record and seizure diary
• At screening, participant must have weight and height values within the 5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control [CDC])
• Participant must never have been treated for epilepsy (treatment-naïve) or have been treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment
• Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation
Exclusion Criteria
Exclusion Criteria:
• Participant has a surgically implanted and functioning vagus nerve stimulator
• Participant has a history of seizures as a result of a correctable medical condition, such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2 weeks prior to the first day of Screening
• Participant has had uncontrolled seizures while previously taking either topiramate or levetiracetam
• Participant has a history of non-epileptic seizures within 2 weeks prior to the first day of Screening
• Participant has myoclonic or absence seizures
• Participant has a surgically implanted and functioning vagus nerve stimulator
• Participant has a history of seizures as a result of a correctable medical condition, such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2 weeks prior to the first day of Screening
• Participant has had uncontrolled seizures while previously taking either topiramate or levetiracetam
• Participant has a history of non-epileptic seizures within 2 weeks prior to the first day of Screening
• Participant has myoclonic or absence seizures
The Estimated Number of Participants
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Taiwan
25 participants
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Global
282 participants
