CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 76 enrolled
Drug / intervention
Maxalt +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00719134
NCT00719134Phase 4Completed

The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

Beth Israel Deaconess Medical Center·interventional·Posted Jul 21, 2008·Updated Apr 9, 2015

In Brief

A Phase 4 clinical trial evaluating Maxalt, placebo pill, and 1 other intervention for Episodic Migraine. Completed, enrolled 76 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.9 years ago

Interventions

Maxaltdrug

anti-migraine drug

placebo pilldrug

placebo pills

placebo pillsdrug

placebo pills