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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 May 2023
• Main ID: NCT02201251
• Date of registration: 24/07/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
• 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
• Date of first enrolment: October 6, 2014
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02201251
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Canada, China, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Philippines, Poland, Russian Federation, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Topiramate

Drug: Levetiracetam

Primary Outcome(s)

Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6 [Time Frame: Baseline up to Month 6]

Change From Baseline in Height Z-score up to Month 1 [Time Frame: Baseline up to Month 1]

Change From Baseline in Weight Z-score up to Month 6 [Time Frame: Baseline up to Month 6]

Change From Baseline in BMD Z-score up to Month 12 [Time Frame: Baseline up to Month 12]

Change From Baseline in Weight Z-score up to Month 12 [Time Frame: Baseline up to Month 12]

Change From Baseline in Weight Z-score up to Month 3 [Time Frame: Baseline up to Month 3]

Change From Baseline in Weight Z-score up to Month 1 [Time Frame: Baseline up to Month 1]

Change From Baseline in Weight Z-score up to Month 9 [Time Frame: Baseline up to Month 9]

Change From Baseline in BMC-Z Score up to Month 12 [Time Frame: Baseline up to Month 12]

Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6 [Time Frame: Baseline up to Month 6]

Change From Baseline in Height Z-score up to Month 12 [Time Frame: Baseline up to Month 12]

Change From Baseline in Height Z-score up to Month 9 [Time Frame: Baseline up to Month 9]

Change From Baseline in Height Z-score up to Month 3 [Time Frame: Baseline up to Month 3]

Change From Baseline in Height Z-score up to Month 6 [Time Frame: Baseline up to Month 6]

Secondary Outcome(s)

Number of Participants With Treatment-emergent Adverse Events (TEAE) [Time Frame: Up to Day 390]

Percentage of Participants With Kidney Stones [Time Frame: Up to Day 390]

Secondary ID(s)

2012-001552-19

TOPMATEPY4067

CR104425

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/05/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02201251