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NCT00355056 · ClinicalTrials.gov registry record · NA
PREMIUM Migraine Trial
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 230
- Enrollment target
NCT00355056: Completed NA study, sponsored by Abbott Medical Devices.
NCT00355056 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 230 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00355056, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 230 participants
- Enrollment target
Study Summary
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
Primary Outcome
A 50% reduction from the monthly number of migraine attacks during the 60-day baseline phase to the monthly number of migraine attacks during month ten through the twelfth month in the treatment phase (device group versus sham group).
Interventions
- OTHER Sham Procedure
- DEVICE AMPLATZER PFO Occluder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2006-01 |
| Est. Completion | 2015-12 |
| Phase | NA |
What the finished NCT00355056 record still lists
NCT00355056 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Procedure is the first listed.
NCT00355056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00355056 about?
NCT00355056 is a clinical study titled "PREMIUM Migraine Trial". The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
What is the current status of trial NCT00355056?
This trial is currently completed. It is a NA study. The enrollment target is 230 participants. The study started on 2006-01. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00355056?
The interventions under investigation include: Sham Procedure (OTHER), AMPLATZER PFO Occluder (DEVICE).
Who is sponsoring clinical trial NCT00355056?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00355056's enrollment target sits among peer trials
230 465th of 2000 higher than 1,533 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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