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The TRACTOR

Migraine Headache Trial

 

What does the Trial involve?

The TRACTOR Migraine Headache Trial, is a medical study, and will test if a blood thinning medication (Brilinta) improves migraine symptoms in patients with PFO.

 

  • All potential participants will be screened for the presence of a PFO using a non-invasive test called a Transcranial Doppler Study.  If the participant does not have a PFO, she/he will be excluded.

  • Each participant will track her/his migraine symptoms daily through an electronic headache log. The participant will receive a daily reminder via e-mail, with a link to log into the TRACTOR database and record headache symptoms over the previous 24 hours.  Completing the log should require less than three minutes a day.

  • After one month of monitoring, the participant will receive the study medication (Brilinta), and take it every day for one month, continuing to record headache symptoms

  • At the end of the second month, the number of headache days on Brilinta will be compared to the number of headache days in the initial month.  Those with a positive response to the medication (> 50% reduction in headaches) will be offered the chance to continue the medicine for another two months.

What is Brilinta?

 

  • Brilinta is a blood thinning medication, also called ticagrelor, which is approved by the FDA for use in patients who have had heart attacks, or who require stents to open blockages in their coronary arteries.

  • Specifically Brilinta inhibits the platelets in the blood, by binding to a specific site on the platelet surface called the P2Y12 receptor.

  • While this drug has not been tested in migraine headache patients before, other P2Y12 blocking agents such as clopidogrel (Plavix) and prasugrel (Effient) were remarkably effective in reducing migraine symptoms in a small study of patients with PFO (Spencer et al.  Cephalalgia 2014:34:933-937.)

  • Brilinta has a potential advantage over the other drugs in that the body does not have to activate the drug to inhibit the platelets.  Some patients are genetically unable to activate clopidogrel and prasugrel, making the potential benefit of those medicines less predictable.

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