Status:
COMPLETED
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Partial Seizure Disorder
Epilepsy
Eligibility:
All Genders
1-24 years
Phase:
PHASE3
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).
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 compar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00113815
Start Date
May 1 2005
End Date
November 1 2007
Last Update
March 26 2014
Active Locations (94)
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Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Los Angeles, California, United States
4
Denver, Colorado, United States