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NCT01112553 · ClinicalTrials.gov registry record
Treximet Migraine Brain Imaging Research Study
A clinical trial, sponsored by Mclean Hospital.
- Terminated
- Registry status
- 2
- Enrollment target
NCT01112553 is a clinical trial that was terminated before completion, run by Mclean Hospital. The registered enrollment target is 2 participants.
The verdict
NCT01112553 was terminated before completion, sponsored by Mclean Hospital.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
We are looking for volunteers who suffer from acute migraine (\<14 episodes per month) to participate in a 2-visit brain imaging research study. The goal of the study is to observe the effect of acute administration of Treximet during a migraine episode on the pain pathways of the migraine brain. Visit 1 will consist of 1 hour, where participants will be signing the informed consent form, completing questionnaires, meeting with the study physician, and having QST (sensory testing to determine individual pain thresholds to a heat stimulus) performed. Visit 2 will occur during a migraine episode. Volunteers will be asked to contact the study team at the first onset of a migraine. Upon arrival at Visit 2, individuals will be given an IV for blood draws. Once these the IV is in place, subjects will enter the MRI and be asked to stay very still. Scanning will occur for about 20 minutes, and then subjects will be given a Treximet tablet to combat their migraine. More scanning will follow Treximet administration. Some scans will have no stimulation, and others will apply a heat stimulus that subjects will rate using a pain scale. Seven 5-mL blood samples will be drawn throughout the duration of the MRI session. Both Visit 1 and Visit 2 will be compensated.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01112553
The ClinicalTrials.gov registry entry for NCT01112553 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01112553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01112553 about?
NCT01112553 is a clinical study titled "Treximet Migraine Brain Imaging Research Study". We are looking for volunteers who suffer from acute migraine (\<14 episodes per month) to participate in a 2-visit brain imaging research study. The goal of the study is to observe the effect of acute administration of Treximet during a migraine episode on the pain pathways of the migraine brain. Vi...
What is the current status of trial NCT01112553?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2010-04. Estimated completion is 2012-10.
Who is sponsoring clinical trial NCT01112553?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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