Trial · NCT02201251

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

NCT02201251, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2021-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy. Trials, record NCT02201251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02201251

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
NCT number: NCT02201251
Status: Completed
Phases: Phase 3
Enrollment: 63 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Epilepsy
Interventions: Topiramate, Levetiracetam
First posted: 2014-07-28
Last updated: 2025-04-29
Other registries' IDs: eudract:2012-001552-19
Results first posted: 2021-05-17
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Weight Z-score up to Month 1	Baseline 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.
Primary	Change From Baseline in Weight Z-score up to Month 3	Baseline 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.
Primary	Change From Baseline in Weight Z-score up to Month 6	Baseline 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.
Primary	Change From Baseline in Weight Z-score up to Month 9	Baseline 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.
Primary	Change From Baseline in Weight Z-score up to Month 12	Baseline 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.
Primary	Change From Baseline in Height Z-score up to Month 1	Baseline 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.
Primary	Change From Baseline in Height Z-score up to Month 3	Baseline 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.
Primary	Change From Baseline in Height Z-score up to Month 6	Baseline 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.
Primary	Change From Baseline in Height Z-score up to Month 9	Baseline 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.
Primary	Change From Baseline in Height Z-score up to Month 12	Baseline 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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Weight Z-score up to Month 1	Baseline up to Month 1	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Weight Z-score up to Month 3	Baseline up to Month 3	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Weight Z-score up to Month 6	Baseline up to Month 6	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Weight Z-score up to Month 9	Baseline up to Month 9	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Weight Z-score up to Month 12	Baseline up to Month 12	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Height Z-score up to Month 1	Baseline up to Month 1	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Height Z-score up to Month 3	Baseline up to Month 3	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Height Z-score up to Month 6	Baseline up to Month 6	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Height Z-score up to Month 9	Baseline up to Month 9	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.	Z-score	MEAN
PRIMARY	Change From Baseline in Height Z-score up to Month 12	Baseline up to Month 12	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.	Z-score	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Weight Z-score up to Month 1	Topiramate	-0.112	Standard Deviation 0.1220	Z-score
Change From Baseline in Weight Z-score up to Month 1	Levetiracetam	-0.014	Standard Deviation 0.1244	Z-score
Change From Baseline in Weight Z-score up to Month 3	Topiramate	-0.201	Standard Deviation 0.2094	Z-score
Change From Baseline in Weight Z-score up to Month 3	Levetiracetam	-0.027	Standard Deviation 0.1802	Z-score
Change From Baseline in Weight Z-score up to Month 6	Topiramate	-0.319	Standard Deviation 0.2496	Z-score
Change From Baseline in Weight Z-score up to Month 6	Levetiracetam	-0.070	Standard Deviation 0.2304	Z-score
Change From Baseline in Weight Z-score up to Month 9	Topiramate	-0.326	Standard Deviation 0.3235	Z-score
Change From Baseline in Weight Z-score up to Month 9	Levetiracetam	-0.110	Standard Deviation 0.3584	Z-score
Change From Baseline in Weight Z-score up to Month 12	Topiramate	-0.351	Standard Deviation 0.3905	Z-score
Change From Baseline in Weight Z-score up to Month 12	Levetiracetam	-0.065	Standard Deviation 0.3026	Z-score

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate	28
Overall Study	STARTED	Levetiracetam	35
Overall Study	COMPLETED	Topiramate	24
Overall Study	COMPLETED	Levetiracetam	32
Overall Study	NOT COMPLETED	Topiramate	4
Overall Study	NOT COMPLETED	Levetiracetam	3

Source ClinicalTrials.gov

Adverse events210

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Eosinophilia	Blood and lymphatic system disorders	Topiramate	0	28
other	Eosinophilia	Blood and lymphatic system disorders	Levetiracetam	1	35
other	Palpitations	Cardiac disorders	Topiramate	1	28
other	Palpitations	Cardiac disorders	Levetiracetam	0	35
other	Ear Pain	Ear and labyrinth disorders	Topiramate	0	28
other	Ear Pain	Ear and labyrinth disorders	Levetiracetam	1	35
other	Middle Ear Effusion	Ear and labyrinth disorders	Topiramate	0	28
other	Middle Ear Effusion	Ear and labyrinth disorders	Levetiracetam	1	35
other	Vertigo	Ear and labyrinth disorders	Topiramate	1	28
other	Vertigo	Ear and labyrinth disorders	Levetiracetam	2	35

1 to 10 of 210Source ClinicalTrials.gov

See all 210 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate	0	28
Total, all-cause mortality	Levetiracetam	0	35
Total, other adverse events	Topiramate	25	28
Total, other adverse events	Levetiracetam	29	35
Total, serious adverse events	Topiramate	0	28
Total, serious adverse events	Levetiracetam	5	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Topiramate vs Levetiracetam: deaths from any cause	Trial comparisons
Topiramate vs Levetiracetam: Number of Participants With Treatment-emergent Adverse Events (TEAE)	Trial comparisons
Topiramate vs Levetiracetam: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02201251

GET https://conductscience.org/api/trials/v1/NCT02201251/results?page=2

API reference For AI assistants