Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
NCT ID: NCT00113815
Last Updated: 2014-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2005-05-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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003
topiramate 25 mg/kg/day
topiramate
25 mg/kg/day
002
topiramate 15 mg/kg/day
topiramate
15 mg/kg/day
001
topiramate 5 mg/kg/day
topiramate
5 mg/kg/day
004
placebo placebo
placebo
placebo
Interventions
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topiramate
15 mg/kg/day
topiramate
5 mg/kg/day
topiramate
25 mg/kg/day
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Concurrent 1 or 2 antiepileptic drugs
* Receiving regular enteral feedings
* Weigh between 3.5 and 15 kg
* Clinical or EEG evidence of simple or complex POS
Exclusion Criteria
* Surgically implanted and functioning vagus nerve stimulator
* Renal stones
* Medically uncontrolled illnesses or conditions
* Infantile seizures as a result of a correctable medical condition
* Progressive neurologic disorder
1 Month
24 Months
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Los Angeles, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Wilmington, Delaware, United States
Washington D.C., District of Columbia, United States
Loxahatchee Groves, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Dearborn, Michigan, United States
Saint Paul, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Cherry Hill, New Jersey, United States
Newark, New Jersey, United States
Buffalo, New York, United States
Mineola, New York, United States
Rochester, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Danville, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Fort Worth, Texas, United States
Plano, Texas, United States
Norfolk, Virginia, United States
Madison, Wisconsin, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
Rio Negro, , Argentina
Santa Fe, , Argentina
Heidelberg West, , Australia
Melbourne, , Australia
Subiaco, , Australia
Antwerp, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Pulderbos, , Belgium
St. John's, Newfoundland and Labrador, Canada
Saskatoon, Saskatchewan, Canada
Chile, , Chile
Santiago, , Chile
Helsinki, , Finland
Tampere, , Finland
Bordeaux, , France
Lille, , France
Tours, , France
Budapest, , Hungary
Chennai, , India
Hyderabad Gpo, , India
Kochi Ho, , India
Mumbai, , India
New Delhi, , India
Pune, , India
Petah Tikva, , Israel
Monterrey, , Mexico
San Luis Potosí City, , Mexico
Heeze, , Netherlands
Wellington, , New Zealand
Bergen, , Norway
Gdansk, , Poland
Warsaw, , Poland
Ekaterinburg Siberia, , Russia
Moscow, , Russia
Omsk Siberia, , Russia
Samara, , Russia
Cape Town Wc, , South Africa
Seoul, , South Korea
Madrid, , Spain
Taipei, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Donetsk, , Ukraine
Kiev, , Ukraine
Countries
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References
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Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.
Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.
Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.
Related Links
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Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
Other Identifiers
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CR002233
Identifier Type: -
Identifier Source: org_study_id
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