Last updated on July 2018

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02201251

Contact Investigators or Research Sites near you

Start Over

Use link at the bottom ...

University of Alabama at Birmingham
Birmingham, AL United States
  Connect »

Use link at the bottom ...

Center for Neurosciences
Tucson, AZ United States
  Connect »

Use link at the bottom ...

Childrens Hospital Los Angeles
Los Angeles, CA United States
  Connect »

Use link at the bottom ...

UCLA
Los Angeles, CA United States
  Connect »

Use link at the bottom ...

University of Florida COM - Division of Pediatric Neurology
Gainesville, FL United States
  Connect »

Use link at the bottom ...

NW Florida Clinical Research Group, LLC
Gulf Breeze, FL United States
  Connect »

Use link at the bottom ...

Pediatric Neurology, Pa
Orlando, FL United States
  Connect »

Use link at the bottom ...

Pediatric Epilepsy and Neurology Specialists
Tampa, FL United States
  Connect »

Use link at the bottom ...

Wellington Counseling Doctors and Clinic
Wellington, FL United States
  Connect »

Use link at the bottom ...

Georgia Regents University
Augusta, GA United States
  Connect »

Use link at the bottom ...

University of Iowa Childrens Hospital
Iowa City, IA United States
  Connect »

Use link at the bottom ...

University of Louisville Child Neurology Division
Louisville, KY United States
  Connect »

Use link at the bottom ...

Boston Children's Hospital
Boston, MA United States
  Connect »

Use link at the bottom ...

Children's Hospital of Michigan
Detroit, MI United States
  Connect »

Use link at the bottom ...

Blythedale Childrens Hospital
Valhalla, NY United States
  Connect »

Use link at the bottom ...

UNC Chapel Hill
Chapel Hill, NC United States
  Connect »

Use link at the bottom ...

Duke University
Durham, NC United States
  Connect »

Use link at the bottom ...

Nationwide Children's Hospitial
Columbus, OH United States
  Connect »

Use link at the bottom ...

The Toledo Children's Hospital: University of Toledo College of Medicine
Toledo, OH United States
  Connect »

Use link at the bottom ...

Oregon Health & Science University
Portland, OR United States
  Connect »

Use link at the bottom ...

The Children's Hospital of Philadelphia
Philadelphia, PA United States
  Connect »

Use link at the bottom ...

Vanderbilt Children's Hospital
Nashville, TN United States
  Connect »

Use link at the bottom ...

Road Runner Research, Ltd.
San Antonio, TX United States
  Connect »

Use link at the bottom ...

Scott & White Clinic
Temple, TX United States
  Connect »

Use link at the bottom ...

University of Utah Health Sciences Center
Salt Lake City, UT United States
  Connect »

Use link at the bottom ...

Seattle Children's Hospital
Seattle, WA United States
  Connect »

Use link at the bottom ...

Dean St. Marys Outpatient Center
Madison, WI United States
  Connect »

Use link at the bottom ...

Instituto de Neurolog a Cognitiva - INECO
Buenos Aires, Argentina
  Connect »

Use link at the bottom ...

Hospital Fleni
Buenos Aires, Argentina
  Connect »

Use link at the bottom ...

Sanatorio Allende
Cordoba, Argentina
  Connect »

Use link at the bottom ...

Hospital De Ni os Sor Maria Ludovica
La Plata, Buenos Aires, Argentina
  Connect »

Use link at the bottom ...

Lady Cilento Childrens Hospital
Queensland, Australia
  Connect »

Use link at the bottom ...

Landeskrankenhaus Bregenz
Bregenz, Austria
  Connect »

Use link at the bottom ...

Medizinische Universit t Graz, Universit tsklinik f r Kinder- und Jugendheilkunde
Graz, Austria
  Connect »

Use link at the bottom ...

Cliniques Universitaires Saint-Luc
Brussels, Belgium
  Connect »

Use link at the bottom ...

UZ Leuven Gasthuisberg
Leuven, Belgium
  Connect »

Use link at the bottom ...

Clinique Ste Elisabeth
Namur, Belgium
  Connect »

Use link at the bottom ...

Alberta Children's Hospital
Calgary, AB Canada
  Connect »

Use link at the bottom ...

Royal University Hospital
Saskatoon, SK Canada
  Connect »

Use link at the bottom ...

Saskatoon Centre for Patient-Oriented Research
Saskatoon, SK Canada
  Connect »

Use link at the bottom ...

Centre Hospitalier d'Amiens - H pital Sud
Amiens, France
  Connect »

Use link at the bottom ...

CHRU Brest - H pital Morvan
Brest, France
  Connect »

Use link at the bottom ...

Hospices Civils de Lyon - Groupement Hospitalier Est - H pital Femme M re Enfant
Bron, France
  Connect »

Use link at the bottom ...

Hopital Robert-Debre - Service de Neuropediatrie et maladies metaboliques
Paris, France
  Connect »

Use link at the bottom ...

CHU de Toulouse Hopital des Enfants
Toulouse, France
  Connect »

Use link at the bottom ...

Klinik f r An sthesiologie und Intesivmedizin
Berlin, Germany
  Connect »

Use link at the bottom ...

Ludwig Maximilian Universitat Munchen Klinikum der Universitat Munchen, Campus Innenstadt
Munchen, Germany
  Connect »

Use link at the bottom ...

Dr. Kenessey A. Hospital
Balassagyarmat, Hungary
  Connect »

Use link at the bottom ...

Fovarosi Onkormanyzat Budai Gyermekkorhaza
Budapest N/A, Hungary
  Connect »

Use link at the bottom ...

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, Hungary
  Connect »

Use link at the bottom ...

cit NEUROPSIQUE
Monterrey, Mexico
  Connect »

Use link at the bottom ...

Sanatorio La Luz
Morelia, Mexico
  Connect »

Use link at the bottom ...

Cebu Doctors University Hospital
Cebu, Philippines
  Connect »

Use link at the bottom ...

Neuroscience Center
Cebu, Philippines
  Connect »

Use link at the bottom ...

University of Santo Tomas Hospital
Manila, Philippines
  Connect »

Use link at the bottom ...

Capitol Medical Center Inc.
Quezon City, Philippines
  Connect »

Use link at the bottom ...

Wojewodzki Specjalistyczny Szpital Dzieciecy sw Ludwika w Krakowie
Krakow, Poland
  Connect »

Use link at the bottom ...

Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po
Poznan, Poland
  Connect »

Use link at the bottom ...

Instytut Pomnik-Centrum Zdrowia Dziecka, Klin. Neurologii i Epileptologi
Warsaw, Poland
  Connect »

Use link at the bottom ...

Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
Warszawa, Poland
  Connect »

Use link at the bottom ...

SBEI of HPE St. Petersburg State Pediatric Medical Academy of Ministry of Health of RFD
Saint Petersburg, Russian Federation
  Connect »

Use link at the bottom ...

State Healthcare Institution "Central Clinical Medical and Sanitary Unit"
Ulyanovsk, Russian Federation
  Connect »

Use link at the bottom ...

Voronezh regional children's hospital # 1
Voronezh, Russian Federation
  Connect »

Use link at the bottom ...

MHCI Clinical Hospital No 8
Yaroslavl, Russian Federation
  Connect »

Use link at the bottom ...

Parklands Hospital
Durban, South Africa
  Connect »

Use link at the bottom ...

Inkosi Albert Luthuli Central Hospital
Durban, South Africa
  Connect »

Use link at the bottom ...

Nelson Mandela Academic Hospital
Mthatha, South Africa
  Connect »

Use link at the bottom ...

Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan
  Connect »

Use link at the bottom ...

Taipei Medical University Shuang-Ho Hospital
New Taipei City, Taiwan
  Connect »

Use link at the bottom ...

China Medical University Hospital
Taichung, Taiwan
  Connect »

Use link at the bottom ...

National Taiwan University Hospital
Taipei, Taiwan
  Connect »

Use link at the bottom ...

Chang Gung Memorial Hospital
Taoyuan, Taiwan
  Connect »

Use link at the bottom ...

AO Spedali Civili di Brescia - Ospedale dei Bambini di Brescia
Brescia, Italy
  Connect »

Use link at the bottom ...

Istituto Giannina Gaslini - Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico
Genova, Italy
  Connect »

Use link at the bottom ...

Azienda Ospedaliero Universitaria Policlinico Gaetano Martino - Messina
Messina, Italy
  Connect »

Use link at the bottom ...

Universita degli Studi di Perugia
Perugia, Italy
  Connect »

Use link at the bottom ...

AOU Policlinico Tor Vergata - Fondazione
Roma, Italy
  Connect »

Use link at the bottom ...

Universit tsklinikum T bingen - Universit ts-Kinderklinik
Tübingen, Germany
  Connect »

Use link at the bottom ...

Csolnoky Ferenc Korhaz
Veszprém, Hungary
  Connect »

Use link at the bottom ...

Consultorio especializado en Psiquiatr a Infantil y Adolescentes
San Luis Potosí, Mexico
  Connect »