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

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Partial Seizure Disorder; Epilepsy; Seizures

Intervention: topiramate (Drug); topiramate (Drug); topiramate (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Summary

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

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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 outcome: 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.

Detailed description: This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.

Eligibility

Minimum age: 1 Month. Maximum age: 24 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 1-24 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

Exclusion Criteria:

- 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

Locations and Contacts

Buenos Aires, Argentina

Cordoba, Argentina

Rio Negro, Argentina

Santa Fe, Argentina

Heidelberg West, Australia

Melbourne, Australia

Subiaco, Australia

Antwerpen, Belgium

Gent, Belgium

Leuven, Belgium

Pulderbos, Belgium

Chile, Chile

Santiago, Chile

Helsinki, Finland

Tampere, Finland

Bordeaux Cedex, France

Lille, France

Tours Cedex 9, France

Budapest, Hungary

Chennai, India

Hyderabad Gpo, India

Kochi Ho, India

Mumbai, India

New Delhi, India

Pune, India

Petah Tikva, Israel

Seoul, Korea, Republic of

Monterrey, Mexico

San Luis Potosi, Mexico

Heeze, Netherlands

Wellington, New Zealand

Bergen, Norway

Gdansk, Poland

Warszawa N/A, Poland

Ekaterinburg Siberia, Russian Federation

Moscow, Russian Federation

Omsk Siberia, Russian Federation

Samara, Russian Federation

Cape Town Wc, South Africa

Madrid, Spain

Taipei, Taiwan

Bangkok, Thailand

Chiangmai, Thailand

Donetsk, Ukraine

Kiev, Ukraine

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, District of Columbia, United States

Loxahatchee, 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

Saint Louis, Missouri, United States

Springfield, 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

St. John'S, Newfoundland and Labrador, Canada

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

Saskatoon, Saskatchewan, Canada

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

Additional Information

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

Starting date: May 2005
Last updated: March 25, 2014

Page last updated: August 23, 2015

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