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

NCT ID: NCT02201251

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-06
• Study Completion Date: 2020-04-30

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.

Detailed Description

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Topiramate

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Levetiracetam

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Birmingham, Alabama, United States

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

Countries

United States; Argentina; Australia; Austria; Belgium; Canada; France; Germany; Hungary; Philippines; Poland; Russia; South Africa; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TOPMATEPY4067

Identifier Type: OTHER

Identifier Source: secondary_id

2012-001552-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR104425

Identifier Type: -

Identifier Source: org_study_id