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NCT00719134 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Episodic Migraine, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
Phase 4
Development phase
76
Enrollment target
1
Study location

NCT00719134 is a Phase 4 study of Episodic Migraine that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 76 participants, below the 491-participant average among 13 other Episodic Migraine trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00719134, a Phase 4 study of Episodic Migraine, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
76 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Episodic Migraine

Interventions

  • DRUG placebo pill
  • DRUG Maxalt
  • DRUG placebo pills

Study Locations (1)

Massachusetts

  • Pain Clinic at Beth Israel Deaconess Medical Center - Brookline

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2008-09
Est. Completion 2013-12
Phase Phase 4

Sponsor

Beth Israel Deaconess Medical Center

488 total trials

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What the Registry Record Tells You About NCT00719134

The ClinicalTrials.gov registry entry for NCT00719134 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 491-participant average among 13 other Episodic Migraine trials with a reported enrollment target (85% lower). The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Episodic Migraine appearing as the primary indexed condition, and to 3 interventions - of which placebo pill is the first listed.

NCT00719134 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00719134 about?

NCT00719134 is a clinical study titled "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 sympt...

What is the current status of trial NCT00719134?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 76 participants. The study started on 2008-09. Estimated completion is 2013-12.

What conditions does trial NCT00719134 study?

This clinical trial studies the following conditions: Episodic Migraine.

What interventions are being tested in trial NCT00719134?

The interventions under investigation include: placebo pill (DRUG), Maxalt (DRUG), placebo pills (DRUG).

Who is sponsoring clinical trial NCT00719134?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00719134 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.