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

Completed · Phase 3 · Has a placebo group

Conditions studied: Partial Seizure Disorder, Epilepsy, Seizures

In brief

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

Key facts

Study ID

NCT00113815

Run by

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

People needed

118

Starts

2005-05-01

Expected to finish

2007-11-01

Last updated by the study team

2014-03-26

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Wilmington, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Loxahatchee Groves, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Dearborn, Michigan, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — Kansas City, Missouri, United States
• Study site — Springfield, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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