Migraine Clinical Trial
Official title:
Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine
Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg
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.
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