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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

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