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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02201251
Registration number
NCT02201251
Ethics application status
Date submitted
24/07/2014
Date registered
28/07/2014
Date last updated
3/05/2023
Titles & IDs
Public title
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
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Scientific title
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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Secondary ID [1]
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0
TOPMATEPY4067
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Secondary ID [2]
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CR104425
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Topiramate
Treatment: Drugs - Levetiracetam
Experimental: Topiramate - Topiramate weight based dosing for participants 2 to less than (\<) 10 years of age not to exceed 350 mg/day (milligram per day), as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.
Active comparator: Levetiracetam - Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 milligram per kilogram per day (mg/kg/day), as tolerated. The maximum recommended daily dosage is 3,000 milligram (mg).
Treatment: Drugs: Topiramate
Topiramate weight based dosing for participants 2 to \<10 years of age not to exceed 350 mg/day, as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.
Treatment: Drugs: Levetiracetam
Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 mg/kg/day, as tolerated. The maximum recommended daily dosage is 3,000 mg.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Weight Z-score up to Month 1
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Assessment method [1]
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The Z-Score indicates how many standard deviations (SD) a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the Statistical Analysis System (SAS) programs provided by the Centers for Disease Control (CDC) for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 1 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [1]
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Baseline up to Month 1
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Primary outcome [2]
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Change From Baseline in Weight Z-score up to Month 3
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Assessment method [2]
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The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 3 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [2]
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Baseline up to Month 3
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Primary outcome [3]
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Change From Baseline in Weight Z-score up to Month 6
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Assessment method [3]
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The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 6 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [3]
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Baseline up to Month 6
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Primary outcome [4]
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Change From Baseline in Weight Z-score up to Month 9
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Assessment method [4]
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The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up yo Month 9 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [4]
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Baseline up to Month 9
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Primary outcome [5]
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Change From Baseline in Weight Z-score up to Month 12
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Assessment method [5]
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The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline to Month 12 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [5]
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0
Baseline up to Month 12
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Primary outcome [6]
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Change From Baseline in Height Z-score up to Month 1
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Assessment method [6]
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Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from minus (-) 3 to plus (+) 3; 0 equal to (=) same mean, greater than (\>) 0 a greater mean, and less than (\<) 0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 1 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [6]
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0
Baseline up to Month 1
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Primary outcome [7]
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Change From Baseline in Height Z-score up to Month 3
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Assessment method [7]
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Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 3 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [7]
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0
Baseline up to Month 3
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Primary outcome [8]
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Change From Baseline in Height Z-score up to Month 6
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Assessment method [8]
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Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 6 for the total safety population for all age cohorts combined were presented.
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Timepoint [8]
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0
Baseline up to Month 6
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Primary outcome [9]
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Change From Baseline in Height Z-score up to Month 9
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Assessment method [9]
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Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 9 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [9]
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0
Baseline up to Month 9
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Primary outcome [10]
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Change From Baseline in Height Z-score up to Month 12
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Assessment method [10]
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Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 12 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
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Timepoint [10]
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Baseline up to Month 12
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Primary outcome [11]
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Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6
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Assessment method [11]
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The BMD was measured by dual energy X-ray absorptiometry (DEXA) for the posterior-anterior lumbar spine (L1_L4) and total body less head area. The Z-Score is the number of standard deviations a participant's BMD differs from the average BMD of their age, sex and ethnicity. Positive scores indicate BMD above the mean; positive values are "best values" and negative values are "worst values". Positive changes from baseline indicated an improvement in condition.
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Timepoint [11]
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Baseline up to Month 6
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Primary outcome [12]
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Change From Baseline in BMD Z-score up to Month 12
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Assessment method [12]
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The BMD was measured by DEXA for the posterior-anterior lumbar spine (L1_L4) and total body less head area. The Z-Score is the number of standard deviations a participant's BMD differs from the average BMD of their age, sex and ethnicity. Positive scores indicate BMD above the mean; positive values are "best values" and negative values are "worst values". Positive changes from baseline indicated an improvement in condition.
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Timepoint [12]
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Baseline up to Month 12
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Primary outcome [13]
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Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6
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Assessment method [13]
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The BMC is an estimate of the amount of mineral (such as calcium) in the bone, which was assessed by DEXA scan for the posterior-anterior lumbar spine (L1_L4) and total body less head area. Positive changes from baseline indicated an improvement in condition.
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Timepoint [13]
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Baseline up to Month 6
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Primary outcome [14]
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Change From Baseline in BMC-Z Score up to Month 12
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Assessment method [14]
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The BMC is an estimate of the amount of mineral (such as calcium) in the bone, which was assessed by DEXA scan for the posterior-anterior lumbar spine (L1_L4) and total body less head area. Positive changes from baseline indicated an improvement in condition.
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Timepoint [14]
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Baseline up to Month 12
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Secondary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events (TEAE)
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
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Timepoint [1]
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Up to Day 390
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Secondary outcome [2]
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Percentage of Participants With Kidney Stones
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Assessment method [2]
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Percentage of participants with kidney stones were reported.
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Timepoint [2]
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Up to Day 390
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Eligibility
Key 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
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Minimum age
2
Years
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Maximum age
15
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/04/2020
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Sample size
Target
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Accrual to date
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Final
63
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Queensland
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Recruitment postcode(s) [1]
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- Queensland
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Country [2]
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0
United States of America
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State/province [2]
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0
California
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Country [3]
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0
United States of America
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State/province [3]
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Florida
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Country [4]
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0
United States of America
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State/province [4]
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0
Kentucky
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Country [5]
0
0
United States of America
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State/province [5]
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0
Ohio
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Country [6]
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0
United States of America
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State/province [6]
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0
Oregon
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
Argentina
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State/province [8]
0
0
Buenos Aires
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Cordoba
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Country [10]
0
0
Austria
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State/province [10]
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0
Graz
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Country [11]
0
0
Belgium
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State/province [11]
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Leuven
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Country [12]
0
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Belgium
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State/province [12]
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Namur
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Country [13]
0
0
Canada
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State/province [13]
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0
Saskatchewan
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Country [14]
0
0
France
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State/province [14]
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0
Brest
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Country [15]
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France
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State/province [15]
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0
Bron
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Country [16]
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0
France
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State/province [16]
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Paris
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Country [17]
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France
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State/province [17]
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0
Toulouse
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Country [18]
0
0
Germany
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State/province [18]
0
0
Munchen
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Country [19]
0
0
Germany
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State/province [19]
0
0
Tübingen
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Country [20]
0
0
Hungary
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State/province [20]
0
0
Balassagyarmat
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Country [21]
0
0
Hungary
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State/province [21]
0
0
Budapest N/a
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Country [22]
0
0
Hungary
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State/province [22]
0
0
Debrecen
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Country [23]
0
0
Hungary
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State/province [23]
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0
Veszprém
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Country [24]
0
0
Philippines
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State/province [24]
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0
Cebu
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Country [25]
0
0
Philippines
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State/province [25]
0
0
Manila
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Country [26]
0
0
Poland
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State/province [26]
0
0
Krakow
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Country [27]
0
0
Poland
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State/province [27]
0
0
Poznan
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Country [28]
0
0
Poland
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State/province [28]
0
0
Warsaw
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Country [29]
0
0
Poland
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State/province [29]
0
0
Warszawa
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Country [30]
0
0
Russian Federation
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State/province [30]
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0
Saint Petersburg
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Country [31]
0
0
Russian Federation
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State/province [31]
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0
Ulyanovsk
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Country [32]
0
0
South Africa
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State/province [32]
0
0
Durban
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Country [33]
0
0
Taiwan
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State/province [33]
0
0
Kaohsiung
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Country [34]
0
0
Taiwan
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State/province [34]
0
0
New Taipei City
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Country [35]
0
0
Taiwan
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State/province [35]
0
0
Taichung
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Country [36]
0
0
Taiwan
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State/province [36]
0
0
Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.
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Trial website
https://clinicaltrials.gov/study/NCT02201251
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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0
Janssen Research & Development, LLC
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
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0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/51/NCT02201251/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/51/NCT02201251/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02201251
Download to PDF