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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03280342
Study type Interventional
Source University of Minnesota
Contact
Status Withdrawn
Phase Phase 2
Start date October 30, 2017
Completion date September 13, 2018

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