NCT00233012

A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures

A Randomized, Open-label (OL), Multicenter Study With OL Extension of the Pharmacokinetics and Safety of Topiramate Administered as Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy in Infants (Aged 1-24 Months, Inclusive) With Refractory Partial-onset Seizures

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is an antiepileptic drug approved for use in adult and pediatric patients (aged 2 to 16 years) with refractory partial onset seizures (POS) with or without secondarily generalized seizures, primary generalized tonic clonic seizures, or Lennox-Gastaut syndrome (LGS).

Detailed description

This is a open-label, randomized (patients are assigned different treatments based on chance), dose comparison, multicenter study of topiramate in infants of age 1-24 months with refractory partial-onset seizures (POS). The trial will evaluate the pharmacokinetics, safety, and tolerability of topiramate used as additional treatment in infants with refractory POS. Topiramate is administered as liquid and sprinkles as adjunct (additional treatment) to concurrent anticonvulsant therapy. The study will consist of 4 phases: a pretreatment phase that includes screening (up to 7 days) and baseline (1 day), an open-label treatment phase (up to 6 weeks), an open-label extension phase (54 weeks), and a posttreatment phase (up to 4 weeks). Seizure diaries will be maintained throughout the study by the patients' parents, legally acceptable representatives, or caregivers. In the open-label treatment phase, patients will be randomly assigned to 1 of 4 treatments: topiramate 3, 5, 15, or 25 mg/kg per day. Venous blood samples (four 1 milliliter \[mL\] samples) will be collected on 2 days during the study to determine plasma concentration of topiramate. Safety will be evaluated throughout the study by monitoring adverse events and by results from clinical laboratory tests (serum chemistry, venous ammonia, hematology, and urinalysis), electrocardiograms (ECGs), vital sign measurements (pulse and blood pressure), physical examination, neurologic examination, Vineland Scales of Adaptive Behavior, renal ultrasound, assessments for adequate food and liquid intake, hyperthermia, oligohydrosis, and rash, and take-home records. Liquid or sprinkles form of topiramate, 3,5,15,or 25mg/kg per day for 54 weeks.

Conditions

• Seizures

Interventions

Type	Name	Description
DRUG	Topiramate

Timeline

• Start date: 2005-06-01
• Completion: 2007-10-01
• First posted: 2005-10-05
• Last updated: 2010-05-25