Clinical trial NCT02201251: A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Topiramate
Levetiracetam
Pediatric
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 63
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change From Baseline in Weight Z-score up to Month 1
timeFrame: Baseline up to Month 1
measure: Change From Baseline in Weight Z-score up to Month 3
timeFrame: Baseline up to Month 3
measure: Change From Baseline in Weight Z-score up to Month 6
timeFrame: Baseline up to Month 6
measure: Change From Baseline in Weight Z-score up to Month 9
timeFrame: Baseline up to Month 9
measure: Change From Baseline in Weight Z-score up to Month 12
timeFrame: Baseline up to Month 12
measure: Change From Baseline in Height Z-score up to Month 1
timeFrame: Baseline up to Month 1
measure: Change From Baseline in Height Z-score up to Month 3
timeFrame: Baseline up to Month 3
measure: Change From Baseline in Height Z-score up to Month 6
timeFrame: Baseline up to Month 6
measure: Change From Baseline in Height Z-score up to Month 9
timeFrame: Baseline up to Month 9
measure: Change From Baseline in Height Z-score up to Month 12
timeFrame: Baseline up to Month 12
measure: Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6
timeFrame: Baseline up to Month 6
measure: Change From Baseline in BMD Z-score up to Month 12
timeFrame: Baseline up to Month 12
measure: Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6
timeFrame: Baseline up to Month 6
measure: Change From Baseline in BMC-Z Score up to Month 12
timeFrame: Baseline up to Month 12
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE)
timeFrame: Up to Day 390
measure: Percentage of Participants With Kidney Stones
timeFrame: Up to Day 390
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Gulf Breeze
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Queensland
country: Australia
city: Graz
country: Austria
city: Leuven
country: Belgium
city: Namur
country: Belgium
city: Saskatoon
country: Canada
state: Saskatchewan
city: Brest
country: France
city: Bron
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Munchen
country: Germany
city: Tübingen
country: Germany
city: Balassagyarmat
country: Hungary
city: Budapest N/a
country: Hungary
city: Debrecen
country: Hungary
city: Veszprém
country: Hungary
city: Cebu
country: Philippines
city: Manila
country: Philippines
city: Krakow
country: Poland
city: Poznan
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Saint Petersburg
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Durban
country: South Africa
city: Kaohsiung
country: Taiwan
city: New Taipei City
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: