Episodic Migraine Clinical Trial
Official title:
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Evidence-based medicine depends on distinguishing between pharmacological effects and
placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously
investigate fundamental questions concerning pharmacological effects, placebo effects and
their interactions. Relief of symptoms of acute migraine will be the test condition for this
scientific experiment because of migraine's evident clinical significance and the
possibility of using participants as their own control during sequential acute migraine
attacks. Our overall goal is to elucidate how the pharmacological effects of 100 mg
rizatriptan (an FDA-proven effective medication for acute migraine) and the effects of
placebo treatment can be modified by varied knowledge and/or expectation ("contextual")
conditions. Such knowledge has the possibility to suggest potentially more efficient
methodologies to test new medications that can be used to augment and enhance the apparatus
of the RCT.
General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo
effect, how such effects vary in different knowledge/expectations contexts, and mutually
constitute one another and interact.
General Hypothesis: The measured pharmacological effect of an effective medication
(rizatriptan) and the measured effect of placebo treatment are determined significantly by
different knowledge/expectations contexts.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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