Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

NCT00113815 | Completed Phase 3

• 1 other identifier: CR002233
• Study Type: interventional
• Target: 118
• Locations: 23 countries
• Sites: 94

Brief Summary

The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

Conditions

Partial Seizure Disorder; Epilepsy; Seizures

Keywords

Partial seizure disorder; Topiramate; Epilepsy; Infants

Outcome Measures

Primary Outcomes (1)

• Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader

  Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader

Secondary Outcomes (1)

• Percent treatment responders >=50% reduction seizure rate. ·Percentage change in seizure rate recorded on subject take-home records. Percentage change in seizure rates for all seizure types recorded on VEEG.

  Baseline to endpoint of double blind phase

Study Arms (4)

003

EXPERIMENTAL

topiramate 25 mg/kg/day

Drug: topiramate

002

EXPERIMENTAL

topiramate 15 mg/kg/day

Drug: topiramate

001

EXPERIMENTAL

topiramate 5 mg/kg/day

Drug: topiramate

004

EXPERIMENTAL

placebo placebo

Drug: placebo

Interventions

topiramate DRUG

15 mg/kg/day

002

placebo DRUG

placebo

004

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• months, inclusive
• 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

You may not qualify if:

• Exclusively breast fed and cannot take medicine by mouth
• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (94)

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Los Angeles, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Loxahatchee Groves, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Dearborn, Michigan, United States

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Saint Paul, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Cherry Hill, New Jersey, United States

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Newark, New Jersey, United States

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Buffalo, New York, United States

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Mineola, New York, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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Syracuse, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Danville, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Germantown, Tennessee, United States

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Fort Worth, Texas, United States

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Plano, Texas, United States

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Norfolk, Virginia, United States

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Madison, Wisconsin, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Rio Negro, Argentina

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Santa Fe, Argentina

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Heidelberg West, Australia

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Melbourne, Australia

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Subiaco, Australia

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Antwerp, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Pulderbos, Belgium

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St. John's, Newfoundland and Labrador, Canada

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Saskatoon, Saskatchewan, Canada

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Chile, Chile

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Santiago, Chile

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Helsinki, Finland

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Tampere, Finland

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Bordeaux, France

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Lille, France

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Tours, France

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Budapest, Hungary

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Chennai, India

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Hyderabad Gpo, India

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Kochi Ho, India

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Mumbai, India

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New Delhi, India

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Pune, India

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Petah Tikva, Israel

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Monterrey, Mexico

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San Luis Potosí City, Mexico

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Heeze, Netherlands

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Wellington, New Zealand

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Bergen, Norway

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Gdansk, Poland

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Warsaw, Poland

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Ekaterinburg Siberia, Russia

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Moscow, Russia

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Omsk Siberia, Russia

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Samara, Russia

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Cape Town Wc, South Africa

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Seoul, South Korea

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Madrid, Spain

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Taipei, Taiwan

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Bangkok, Thailand

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Chiang Mai, Thailand

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Donetsk, Ukraine

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Kiev, Ukraine

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Related Publications (3)

• 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.

  PMID: 20089937 RESULT

• 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.

  PMID: 22633629 DERIVED

• 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.

  PMID: 21673279 DERIVED

Related Links

• Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Seizures

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2005
• First Posted: June 13, 2005
• Study Start: May 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

AR (4); AU (3); NL (1); ES (1); TW (1); CA (2); HU (1); TH (2); KR (1); ME (2); CL (2); FR (3); US (47); IN (6); NZ (1); RU (4); ZA (1); PL (2); NO (1); FI (2); BE (4); IL (1); UA (2)