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NCT00449540 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura

A Phase 3 study of Migraine With Aura, sponsored by Neuralieve.

Completed
Registry status
Phase 3
Development phase
201
Enrollment target
14
Study locations

NCT00449540 is a Phase 3 study of Migraine With Aura that has completed, run by Neuralieve. The registered enrollment target is 201 participants, above the 141-participant average among 6 other Migraine With Aura trials with a reported enrollment target (43% higher). The trial reports 14 study locations across 12 states.

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The verdict

NCT00449540, a Phase 3 study of Migraine With Aura, has completed, sponsored by Neuralieve.

COMPLETED
Registry status
Phase 3
Development phase
201 participants
Enrollment target
14
Study locations

Study Summary

Assess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of migraine with aura The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop or interrupt the spreading cortical brain activity that causes or contributes to the migraine headache. Two TMS treatments at an intensity of \<1 Tesla for \~500 microseconds, approximately 30 seconds apart, may stop the aura and prevent the subsequent headache.

Conditions Studied

Migraine With Aura

Interventions

  • DEVICE Active Transcranial Magnetic Stimulation (TMS) Device
  • DEVICE Sham TMS Device

Study Locations (14)

Michigan

  • Michigan Head Pain & Neurological Institute - Ann Arbor
  • Westside Family Medical Center - Kalamazoo

Missouri

  • Clinvest, Inc. - Springfield
  • Mercy Health Research - St Louis

California

  • San Francisco Headache Clinic - San Francisco

Colorado

  • Mile High Research Center - Denver

Illinois

  • Diamond Headache Clinic, LTD - Chicago

Nebraska

  • Kirchner Headache Clinic - Omaha

New York

  • Montefiore Headache Center - The Bronx

Ohio

  • The Ohio State University - Columbus

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2006-08
Est. Completion 2008-03
Phase Phase 3

Sponsor

Neuralieve

1 total trials

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What the Registry Record Tells You About NCT00449540

The ClinicalTrials.gov registry entry for NCT00449540 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 141-participant average among 6 other Migraine With Aura trials with a reported enrollment target (43% higher). The listed sponsor is Neuralieve, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Migraine With Aura appearing as the primary indexed condition, and to 2 interventions - of which Active Transcranial Magnetic Stimulation (TMS) Device is the first listed.

NCT00449540 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Michigan, Missouri, California.

Frequently Asked Questions

What is clinical trial NCT00449540 about?

NCT00449540 is a clinical study titled "Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura". Assess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of migraine with aura The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop or interrupt the spreading cortical brain activity that causes or contributes to the migraine h...

What is the current status of trial NCT00449540?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2006-08. Estimated completion is 2008-03.

What conditions does trial NCT00449540 study?

This clinical trial studies the following conditions: Migraine With Aura.

What interventions are being tested in trial NCT00449540?

The interventions under investigation include: Active Transcranial Magnetic Stimulation (TMS) Device (DEVICE), Sham TMS Device (DEVICE).

Who is sponsoring clinical trial NCT00449540?

This trial is sponsored by Neuralieve, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00449540 being conducted?

This trial has 14 study locations across California, Colorado, Illinois, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.