Topamax Clinical Pharmacology

HealthCentral.com

Drug Library
Topamax - Clinical Pharmacology [Topiramate]

Following randomization, patients began the double-blind phase of treatment. Patients received active drug beginning at 25 or 50 mg per day; the dose was then increased by 25 mg to 150 mg/ day increments every other week until the assigned dosage of 125, 175, 225, or 400 mg/ day based on patients' weight to approximate a dosage of 6 mg/ kg per day was reached, unless intolerance prevented increases. After titration, patients entered an 8-week stabilization period.

Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures

The effectiveness of topiramate as an adjunctive treatment for primary generalized tonic-clonic seizures in patients 2 years old and older was
established in a multicenter, randomized, double-blind, placebo-controlled trial, comparing a single dosage of topiramate and placebo. Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX Ž or placebo. Patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Patients who experienced at least three primary generalized tonic-clonic seizures during the baseline phase were randomly assigned to placebo or TOPAMAX Ž in addition to their other AEDs.

Following randomization, patients began the double-blind phase of treatment. Patients received active drug beginning at 50 mg per day for four weeks; the dose was then increased by 50 mg to 150 mg/ day increments every other week until the assigned dose of 175, 225, or 400 mg/ day based on patients' body weight to approximate a dosage of 6 mg/ kg per day was reached, unless intolerance prevented increases. After titration, patients entered a 12-week stabilization period.

Controlled Trial in Patients With Lennox-Gastaut Syndrome

The effectiveness of topiramate as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome was established in a multicenter, randomized, double-blind, placebo-controlled trial comparing a single dosage of topiramate with placebo in patients 2 years of age and older.