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| ID | Type | Description | Link |
|---|---|---|---|
| TOPMATEPY4067 | Other Identifier | Janssen Research & Development, LLC | |
| 2012-001552-19 | EudraCT Number |
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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.
This is a randomized (study medication assigned to participants by chance), open-label, multi-centric (conducted in more than one center) and 2-arm flexible-dose monotherapy study of topiramate compared with 1 another AED (levetiracetam) in pediatric participants with epilepsy. The total study duration will be up to of 1 year and 2 months per participant. The study consists of 3 parts: Screening (that is, up to 35 days before study commences on Day 1); Treatment (1 year) and post-treatment (30 days). Safety will primarily be evaluated by percentage of participants with kidney stones and change from baseline in bone mineral density at Month 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Experimental | 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. |
|
| Levetiracetam | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weight Z-score up to Month 1 | 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. | Baseline up to Month 1 |
| Change From Baseline in Weight Z-score up to Month 3 | 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. | Baseline up to Month 3 |
| Change From Baseline in Weight Z-score up to Month 6 | 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. | Baseline up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | 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. | Up to Day 390 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate | Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2017 | Apr 23, 2021 |
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| Levetiracetam | Drug | 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. |
|
| Change From Baseline in Weight Z-score up to Month 9 | 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. | Baseline up to Month 9 |
| Change From Baseline in Weight Z-score up to Month 12 | 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. | Baseline up to Month 12 |
| Change From Baseline in Height Z-score up to Month 1 | 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. | Baseline up to Month 1 |
| Change From Baseline in Height Z-score up to Month 3 | 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. | Baseline up to Month 3 |
| Change From Baseline in Height Z-score up to Month 6 | 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. | Baseline up to Month 6 |
| Change From Baseline in Height Z-score up to Month 9 | 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. | Baseline up to Month 9 |
| Change From Baseline in Height Z-score up to Month 12 | 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. | Baseline up to Month 12 |
| Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6 | 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. | Baseline up to Month 6 |
| Change From Baseline in BMD Z-score up to Month 12 | 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. | Baseline up to Month 12 |
| Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6 | 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. | Baseline up to Month 6 |
| Change From Baseline in BMC-Z Score up to Month 12 | 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. | Baseline up to Month 12 |
| Percentage of Participants With Kidney Stones | Percentage of participants with kidney stones were reported. | Up to Day 390 |
| Los Angeles |
| California |
| United States |
| Gulf Breeze | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Wellington | Florida | United States |
| Louisville | Kentucky | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Portland | Oregon | United States |
| San Antonio | Texas | United States |
| Temple | Texas | United States |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| Queensland | Australia |
| Graz | Austria |
| Leuven | Belgium |
| Namur | Belgium |
| Saskatoon | Saskatchewan | Canada |
| Brest | France |
| Bron | France |
| Paris | France |
| Toulouse | France |
| München | Germany |
| Tübingen | Germany |
| Balassagyarmat | Hungary |
| Budapest | Hungary |
| Debrecen | Hungary |
| Veszprém | Hungary |
| Cebu | Philippines |
| Manila | Philippines |
| Krakow | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| Saint Petersburg | Russia |
| Ulyanovsk | Russia |
| Durban | South Africa |
| Kaohsiung City | Taiwan |
| New Taipei City | Taiwan |
| Taichung | Taiwan |
| Taipei | Taiwan |
| FG001 | Levetiracetam | Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
| BG001 | Levetiracetam | Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Weight Z-score up to Month 1 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 1 |
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| Primary | Change From Baseline in Weight Z-score up to Month 3 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 3 |
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| Primary | Change From Baseline in Weight Z-score up to Month 6 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 6 |
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| Primary | Change From Baseline in Weight Z-score up to Month 9 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 9 |
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| Primary | Change From Baseline in Weight Z-score up to Month 12 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 12 |
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| Primary | Change From Baseline in Height Z-score up to Month 1 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 1 |
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| Primary | Change From Baseline in Height Z-score up to Month 3 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 3 |
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| Primary | Change From Baseline in Height Z-score up to Month 6 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 6 |
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| Primary | Change From Baseline in Height Z-score up to Month 9 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 9 |
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| Primary | Change From Baseline in Height Z-score up to Month 12 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 12 |
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| Primary | Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies the number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 6 |
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| Primary | Change From Baseline in BMD Z-score up to Month 12 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified category. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 12 |
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| Primary | Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified category. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 6 |
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| Primary | Change From Baseline in BMC-Z Score up to Month 12 | 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. | The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified category. | Posted | Mean | Standard Deviation | Z-score | Baseline up to Month 12 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to Day 390 |
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| Secondary | Percentage of Participants With Kidney Stones | Percentage of participants with kidney stones were reported. | Safety analysis set included all randomized subjects who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Up to Day 390 |
|
Up to Day 390
The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topiramate | Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. | 0 | 28 | 0 | 28 | 25 | 28 |
| EG001 | Levetiracetam | Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. | 0 | 35 | 5 | 35 | 29 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skull Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Middle Ear Effusion | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Epigastric Discomfort | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Paraesthesia Oral | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sluggishness | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Gastroenteritis Enteroviral | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Gastrointestinal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Impetigo | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumococcal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pulpitis Dental | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Respiratory Tract Infection Viral | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Scarlet Fever | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Staphylococcal Pharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Systemic Viral Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Lip Injury | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ammonia Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Potassium Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vitamin D Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Balance Disorder | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Cognitive Disorder | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Disturbance in Attention | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Dizziness Exertional | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Memory Impairment | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Mental Impairment | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Partial Seizures | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Psychomotor Hyperactivity | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Affective Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Attention Deficit/Hyperactivity Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Emotional Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hyposomnia | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Learning Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Mood Swings | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Sleep Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Throat Tightness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Keratosis Pilaris | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
Due to futility of enrollment, the enrollment was stopped early; however, all enrolled participants completed the full course of the trial excluding 7 participants (reasons captured in "participant flow"). Also, there was no exposure to topiramate in 2 to 5 years age cohort. Therefore, no conclusions can be made with regard to this age group due to the absence of comparability.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director - Clinical Leader | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2020 | Apr 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077236 | Topiramate |
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| CANADA |
|
| HUNGARY |
|
| ITALY |
|
| PHILIPPINES |
|
| POLAND |
|
| RUSSIAN FEDERATION |
|
| TAIWAN |
|
| UNITED STATES |
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
| Levetiracetam |
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
|
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. |
|
|
Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
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