Phase 3 N=63 Randomized Health Services Research

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

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT02201251 ↗

Enrolled (actual)

Serious AEs

7.9%

Results posted

May 2021

Primary outcome: Primary: Change From Baseline in Weight Z-score up to Month 1 — -0.112; -0.014 Z-score

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Topiramate (Drug); Levetiracetam (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Janssen Research & Development, LLC
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Weight Z-score up to Month 1	-0.112; -0.014	—
PRIMARY Change From Baseline in Weight Z-score up to Month 3	-0.201; -0.027	—
PRIMARY Change From Baseline in Weight Z-score up to Month 6	-0.319; -0.070	—
PRIMARY Change From Baseline in Weight Z-score up to Month 9	-0.326; -0.110	—
PRIMARY Change From Baseline in Weight Z-score up to Month 12	-0.351; -0.065	—
PRIMARY Change From Baseline in Height Z-score up to Month 1	0.004; -0.015	—
PRIMARY Change From Baseline in Height Z-score up to Month 3	-0.036; 0.017	—
PRIMARY Change From Baseline in Height Z-score up to Month 6	-0.008; 0.077	—
PRIMARY Change From Baseline in Height Z-score up to Month 9	-0.059; 0.086	—
PRIMARY Change From Baseline in Height Z-score up to Month 12	-0.057; 0.088	—
PRIMARY Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6	-0.181; 0.035; -0.180; 0.102	—
PRIMARY Change From Baseline in BMD Z-score up to Month 12	-0.346; 0.084; -0.367; 0.054	—
PRIMARY Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6	-0.141; 0.075; -0.242; 0.151	—
PRIMARY Change From Baseline in BMC-Z Score up to Month 12	-0.274; 0.124; -0.266; 0.017	—
SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAE)	25; 29	—
SECONDARY Percentage of Participants With Kidney Stones	0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Participant with a clinical diagnosis of new-onset or recent-onset epilepsy characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening
Caregivers (parents or legally acceptable representatives) of the participant must be able to accurately maintain the participant take-home record and seizure diary
At screening, participant must have weight and height values within the 5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control [CDC])
Participant must never have been treated for epilepsy (treatment-naïve) or have been treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment
Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02201251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.