Clinical trial

A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in…

NCT00233012 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed

Key facts

NCT number NCT00233012
Title A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures
Official title 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
Lead sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry
Status Completed
Phase Phase 1
Study type Interventional
Conditions Seizures
Intervention type Drug
Interventions Topiramate
Enrollment 16
Start date Jun 1, 2005
Completion Oct 1, 2007
First posted Oct 5, 2005
Last update posted May 25, 2010

At a glance

  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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