Ticagrelor Therapy for RefrACTORy Migraine Study

NCT02518464 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: AAAO4109
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Headache; Migraine Headache

Keywords

headache; chronic; migraine; right to left shunt

Outcome Measures

Primary Outcomes (1)

• Total Number of Responders

  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.

  1 month from baseline

Study Arms (1)

Ticagrelor 90 mg twice per day

EXPERIMENTAL

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

Interventions

Ticagrelor 90 mg twice per day DRUG

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.

Also known as: Brilinta

Ticagrelor 90 mg twice per day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• AstraZeneca: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 30478067 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache; Bronchiolitis Obliterans Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Robert Sommer, MD
• Organization: Columbia University Medical Center

rs2463@cumc.columbia.edu

212-305-7060

Study Officials

• Robert J Sommer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 7, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-06

Locations

US (1)