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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00566254 |
Purpose
The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy; Paediatric Partial Onset Seizures |
Drug: Zonisamide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures |
| Estimated Enrollment: | 266 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Placebo Comparator |
Drug: Zonisamide
8mg/kg per day for approximately 24 weeks.
|
This will be a double-blind, randomised, study comparing zonisamide with placebo: each arm will consist of 133 subjects. Zonisamide/placebo dosing will commence with a dose of 1 mg/kg. Further dose increases will occur at weekly intervals until a dose of 8 mg/kg is reached at the end of Week 8. In the event of dose limiting adverse events (AEs), during the eight week Titration Period, one down titration to a lower dose is permitted, this can happen at any point in the Titration Period. Subjects who require further down titration steps will be withdrawn from the study. During the Maintenance Period the dose of study medication must remain unchanged.
Changes in concomitant AEDs are not permitted during the Screening, Titration or Maintenance Periods.
This trial consists of the following periods:
Following the Maintenance Period subjects will have the opportunity to enter an open label extension study. This open label extension study will be the subject of a separate protocol and will not be discussed further at this time.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject is taking a stable regimen of one or two other AEDs for at least one month prior to Visit 1 (start of the Screening Period).
NOTE: If using a vagal nerve stimulator (VNS), it must have been implanted for at least five months and stimulator parameters must remain unchanged for at least one month prior to Visit 1 (start of the Screening Period), and throughout the entire study period. VNS will be considered as one AED for the purposes of this study.
Exclusion Criteria:
Female subject of 10 years of age or greater or of child bearing potential (i.e., started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e., oral contraceptive pill, surgical sterilization, an implant or an injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and one month after last administration of study medication.
NOTE: Should a female subject become of childbearing potential during the study, they must be reconsented in order to give consent to undergo pregnancy testing and either confirm abstinence or receive medically appropriate form of contraception.
Contacts and Locations| Contact: Medical Information Department - Eisai Limited | +44 (0)20 8600 1400 |
Hide Study Locations| Belgium | |
| U.Z Gasthuisberg | Recruiting |
| Leuven, Belgium, 3000 | |
| U.Z Gent | Recruiting |
| Gent, Belgium, 9000 | |
| Universitair Ziekenhuis Brussel | Recruiting |
| Brussels, Belgium, 1090 | |
| Universitair Kinderziekenhuis Koningin Fabiola | Recruiting |
| Brussels, Belgium, 1020 | |
| Estonia | |
| Tartu University Hospital | Recruiting |
| Tartu, Estonia, 51014 | |
| Tallinn Children's Hospital | Recruiting |
| Tallinn, Estonia, 13419 | |
| France | |
| Hopital Charles Nicolle | Recruiting |
| Rouen, France, 76031 | |
| CHRU Roger Salengro | Recruiting |
| Lille, France, 59037 | |
| CHU Timone Enfants | Recruiting |
| Marseille cedex 05, France, 13385 | |
| Hopital Necker | Recruiting |
| Paris, France, 75015 | |
| Hopital Raymond Poincare | Recruiting |
| Garches, France, 92380 | |
| Hopital des Enfants, CHU Pellegrin | Recruiting |
| Bordeaux, France, 33076 | |
| Hungary | |
| Paediatric Clinic | Recruiting |
| Pecs, Hungary, 7623 | |
| Bethesda Children Hospital Budapest | Recruiting |
| Budapest, Hungary, 1143 | |
| Semmelweis University | Recruiting |
| Budapest, Hungary, 1097 | |
| Budai Gyermekkorhaz Kht. Epilepsy Center | Recruiting |
| Budapest, Hungary, 1025 | |
| Borsod-Abauj-Zemplen County Hospital | Recruiting |
| Miskolc, Hungary, 3526 | |
| Paediatric Clinic, University Debrecen | Recruiting |
| Debrecen, Hungary, 4012 | |
| Italy | |
| Ospedali Civili | Recruiting |
| Brescia, Italy, 25123 | |
| Ospedale Carlo Poma | Recruiting |
| Mantova, Italy, 40100 | |
| Istituto Neurologico Casimiro Mondino | Recruiting |
| Pavia, Italy, 27100 | |
| U.O. Istituto Nazionale Neurologico Besta | Recruiting |
| Milano, Italy, 20133 | |
| Ospedale Maggiore | Recruiting |
| Bologna, Italy, 40133 | |
| Ospedale Anna Meyer | Recruiting |
| Firenze, Italy, 50132 | |
| Latvia | |
| Children's Clinical University Hospital | Recruiting |
| Riga, Latvia, LV-1004 | |
| Health Centre of Valmiera | Recruiting |
| Valmiera, Latvia, LV-4201 | |
| Poland | |
| Specjalistyczny Gabinet | Recruiting |
| Poznan, Poland, 61-493 | |
| Samodzielny Publiczny Szpital Kliniczny | Recruiting |
| Katowice, Poland, 40-752 | |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" | Recruiting |
| Warszawa, Poland, 04-730 | |
| Centrum Neurologii Dzieciecej | Recruiting |
| Olsztyn., Poland, 10-959 | |
| Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Recruiting |
| Poznan, Poland, 60-355 | |
| Akademickie Centrum Kliniczne-Szpital AM w Gdansku | Recruiting |
| Gdansk, Poland, 80-952 | |
| Spain | |
| Hosp. Clinico San Carlos - Udad.de Neuropediatria | Recruiting |
| Madrid, Spain, 28040 | |
| Hosp. Univ. Marques de Valdecilla | Recruiting |
| Santander, Spain, 39008 | |
| Hosp. Universitario Virgen del Rocio | Recruiting |
| Sevilla, Spain, 41006 | |
| Hosp. San Juan de Deu | Recruiting |
| Barcelona, Spain, 08950 | |
| Hosp. Univer. Virgen de la Arrixaca | Recruiting |
| Murcia - El Palmar, Spain, 30120 | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 2804 | |
| Ukraine | |
| Lviv Regional Clinical Hospital | Recruiting |
| Lviv, Ukraine, 79010 | |
| Institute of Children and Adolescents Health of AMS of Ukraine | Recruiting |
| Kharkov, Ukraine, 61153 | |
| Institute of Neurology, Psychiatry and Narcology | Recruiting |
| Kharkov, Ukraine, 61068 | |
| City Children Hospital - Number 5 | Recruiting |
| Dnepropetrovsk, Ukraine, 49027 | |
| Odessa SMU, Region Children Clinical Hospital | Recruiting |
| Odessa, Ukraine, 65031 | |
| Study Director: | Rob van Maanen, M.D., MFPM | Eisai Limited |
More Information
| Responsible Party: | Eisai Limited ( Medical Information Department ) |
| Study ID Numbers: | E2090-E044-312, 2006-002515-27 |
| Study First Received: | November 29, 2007 |
| Last Updated: | September 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00566254 History of Changes |
| Health Authority: | European Union: European Medicines Agency |
|
Epilepsy paediatric partial onset seizures |
|
Antioxidants Molecular Mechanisms of Pharmacological Action Seizures Nervous System Diseases Zonisamide Physiological Effects of Drugs Central Nervous System Diseases Brain Diseases |
Protective Agents Pharmacologic Actions Signs and Symptoms Epilepsy Therapeutic Uses Neurologic Manifestations Central Nervous System Agents Anticonvulsants |