Ticagrelor Therapy for RefrACTORy Migraine Study (TRACTOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02518464|
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache Migraine Headache||Drug: Ticagrelor 90 mg twice per day||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Ticagrelor 90 mg twice per day
Interventions include the following: All participants will have a loading dose of Ticagrelor (Brilinta) 180 mg administered in the office at the time of enrollment. Thereafter, for 28 days, Ticagrelor 90 mg tablet will be taken once in the morning and once in the evening, as close to 12 hours apart as possible. Each day, the subject will receive a text message reminder to login to the website, to record her/his headache activity.
Drug: Ticagrelor 90 mg twice per day
Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches.
Other Name: Brilinta
- Total Number of Responders [ Time Frame: 1 month from baseline ]A participant will be considered to have achieved the primary efficacy endpoint (a "Responder") if she/he has >50% reduction in the number of monthly headache days during the month of therapy compared with participant's own baseline. If there is < 50% reduction in the number of migraine days, she/he will be considered a Non-Responder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518464
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert J Sommer, MD||Columbia University|