Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
TOPMATEPY4067
Query!
Secondary ID [2]
0
0
CR104425
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Epilepsy
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Weight Z-score up to Month 1
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline up to Month 1
Query!
Primary outcome [2]
0
0
Change From Baseline in Weight Z-score up to Month 3
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline up to Month 3
Query!
Primary outcome [3]
0
0
Change From Baseline in Weight Z-score up to Month 6
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline up to Month 6
Query!
Primary outcome [4]
0
0
Change From Baseline in Weight Z-score up to Month 9
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline up to Month 9
Query!
Primary outcome [5]
0
0
Change From Baseline in Weight Z-score up to Month 12
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline up to Month 12
Query!
Primary outcome [6]
0
0
Change From Baseline in Height Z-score up to Month 1
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline up to Month 1
Query!
Primary outcome [7]
0
0
Change From Baseline in Height Z-score up to Month 3
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline up to Month 3
Query!
Primary outcome [8]
0
0
Change From Baseline in Height Z-score up to Month 6
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline up to Month 6
Query!
Primary outcome [9]
0
0
Change From Baseline in Height Z-score up to Month 9
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline up to Month 9
Query!
Primary outcome [10]
0
0
Change From Baseline in Height Z-score up to Month 12
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline up to Month 12
Query!
Primary outcome [11]
0
0
Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline up to Month 6
Query!
Primary outcome [12]
0
0
Change From Baseline in BMD Z-score up to Month 12
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline up to Month 12
Query!
Primary outcome [13]
0
0
Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline up to Month 6
Query!
Primary outcome [14]
0
0
Change From Baseline in BMC-Z Score up to Month 12
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline up to Month 12
Query!
Secondary outcome [1]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to Day 390
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Kidney Stones
Query!
Assessment method [2]
0
0
Percentage of participants with kidney stones were reported.
Query!
Timepoint [2]
0
0
Up to Day 390
Query!
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
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
15
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Health Services Research
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/10/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/04/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
63
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Queensland
Query!
Recruitment postcode(s) [1]
0
0
- Queensland
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Ohio
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Oregon
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Buenos Aires
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Cordoba
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Graz
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Leuven
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Namur
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Saskatchewan
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Brest
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Bron
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Paris
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Toulouse
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Munchen
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Tübingen
Query!
Country [20]
0
0
Hungary
Query!
State/province [20]
0
0
Balassagyarmat
Query!
Country [21]
0
0
Hungary
Query!
State/province [21]
0
0
Budapest N/a
Query!
Country [22]
0
0
Hungary
Query!
State/province [22]
0
0
Debrecen
Query!
Country [23]
0
0
Hungary
Query!
State/province [23]
0
0
Veszprém
Query!
Country [24]
0
0
Philippines
Query!
State/province [24]
0
0
Cebu
Query!
Country [25]
0
0
Philippines
Query!
State/province [25]
0
0
Manila
Query!
Country [26]
0
0
Poland
Query!
State/province [26]
0
0
Krakow
Query!
Country [27]
0
0
Poland
Query!
State/province [27]
0
0
Poznan
Query!
Country [28]
0
0
Poland
Query!
State/province [28]
0
0
Warsaw
Query!
Country [29]
0
0
Poland
Query!
State/province [29]
0
0
Warszawa
Query!
Country [30]
0
0
Russian Federation
Query!
State/province [30]
0
0
Saint Petersburg
Query!
Country [31]
0
0
Russian Federation
Query!
State/province [31]
0
0
Ulyanovsk
Query!
Country [32]
0
0
South Africa
Query!
State/province [32]
0
0
Durban
Query!
Country [33]
0
0
Taiwan
Query!
State/province [33]
0
0
Kaohsiung
Query!
Country [34]
0
0
Taiwan
Query!
State/province [34]
0
0
New Taipei City
Query!
Country [35]
0
0
Taiwan
Query!
State/province [35]
0
0
Taichung
Query!
Country [36]
0
0
Taiwan
Query!
State/province [36]
0
0
Taipei
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02201251
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02201251
Download to PDF