Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine

  • STATUS
    Not Recruiting
  • participants needed
    60
  • sponsor
    University of Minnesota - Clinical and Translational Science Institute
Updated on 23 January 2021
migraine
headache
topiramate
hormone replacement therapy
episodic migraine

Summary

Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg

Description

The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax, to an extended-release topiramate (XR-TPM), namely Trokendi XR, regimen on cognition in adults with migraine.

The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used to determine drug exposure response relationships.

Details
Condition Migraine, Headache
Treatment IR-TPM (Topamax), XR-TPM (Trokendi XR)
Clinical Study IdentifierNCT03280342
SponsorUniversity of Minnesota - Clinical and Translational Science Institute
Last Modified on23 January 2021

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