Phase 4
N=40
Ticagrelor Therapy for RefrACTORy Migraine Study
Migraine · Headache · Migraine Headache
Bottom Line
View on ClinicalTrials.gov: NCT02518464 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Total Number of Responders — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor 90 mg twice per day (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Responders |
17 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02518464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.