Clinical trial NCT02518464: Ticagrelor Therapy for RefrACTORy Migraine Study
Official title: Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Headache
Migraine Headache
Keywords: headache
chronic
migraine
right to left shunt
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2015-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg by mouth (PO) twice a day) reduces episodic and/or chronic migraine headache symptoms in patients with right to left shunt. Headache frequency while on Brilinta/ticagrelor will be compared with the documented baseline for each subject. If the Brilinta/ticagrelor therapy was effective (\> 50% reduction in monthly headache days), the subject could elect to continue therapy for an additional two months (56 days), while continuing to complete daily headache logs.

Detailed description: Migraine headaches are poorly understood, and can be severely debilitating. Many types of drugs have been tried in migraine sufferers including anti-depressants, anti-seizure medications, blood pressure medicines and others. The investigators have shown that in a small number of patients, a certain type of blood thinner (Clopidogrel) can reduce or eliminate migraine headaches in patients who also have a hole in the heart wall that allows flow from the right side of the heart to the left. Ticagrelor is a blood thinning drug which works in the same way as the clopidogrel, but is broken down by the body differently and thus allows everyone to use it. The investigators wish to test this medication to see if it works as well, or better than the clopidogrel.

Eligibility criteria: Inclusion Criteria:

* At least one year history of Episodic or Chronic migraine headache symptoms
* At least 6 headache days per month
* Subject able to complete online daily headache log

Exclusion Criteria:

* Inability to understand the study or history of non-compliance with medical advice
* Currently taking a P2Y12 inhibitor
* Known hypersensitivity to Brilinta/ticagrelor
* History of stroke/transient ischemic attack (TIA) in the previous 6 months
* Active bleeding from any site
* Active peptic ulcer disease or upper gastrointestinal (GI) bleeding within six (6) months
* Migraine onset after 50 years of age
* Renal impairment: Creatinine Clearance \< 60 cc/min
* Severe hepatic impairment with total bilirubin \> 3.0 mg/dL
* Thrombocytopenia with platelet count \< 100,000 / ul
* History of intracranial hemorrhage
* Contraindications to blood thinner therapy or history of major bleeding episode while taking blood thinner therapy
* Need for chronic oral anti-coagulation therapy (i.e. Atrial Fibrillation)
* Need for chronic anti-platelet therapy (i.e. drug-eluting (DE) Stent), including daily aspirin use
* Need for daily nonsteroidal anti-inflammatory drug (NSAID) use
* Need for daily carbamazepine therapy or other strong CYP3A inhibitors or potent CYP3A inducers
* Need for simvastatin or lovastatin greater than 40 mg daily
* Symptomatic bradycardia or syncope
* Pregnancy or currently breast-feeding, or plan to become pregnant during the study period
* Planned surgery during the study time-frame
* Previously implanted patent foramen ovale (PFO), atrial septal defect (ASD), pacemaker, inferior vena cava filter, or left atrial appendage closure device

Primary outcomes:
measure: Total Number of Responders
timeFrame: 1 month from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Robert J Sommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reisman AM, Robbins BT, Chou DE, Yugrakh MS, Gross GJ, Privitera L, Nazif T, Sommer RJ. Ticagrelor for Refractory Migraine/Patent Foramen Ovale (TRACTOR): An open-label pilot study. Neurology. 2018 Nov 27;91(22):1010-1017. doi: 10.1212/WNL.0000000000006573.