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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: Completed Phase 3 study of Migraine With Aura, sponsored by Neuralieve.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00449540 record still lists
NCT00449540 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 141-participant average among 6 other Migraine With Aura trials with a reported enrollment target (43% higher).
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 lists 14 locations in 12 states (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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