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Comparing Migraine Preventive Therapies vs. Anti-CGRP Therapies for Tinnitus in Patients With Migraine (COMPACT-PM)
Sponsor: Stanford University
Summary
Many people with migraine also experience tinnitus - a persistent ringing, buzzing, or hissing in the ears - and research suggests these conditions share underlying biological mechanisms, including a protein called calcitonin gene-related peptide (CGRP) that is active in both the brain and the inner ear. COMPACT-PM is a randomized trial comparing two classes of migraine preventive medications in adults with bothersome tinnitus and a history of migraine: anti-CGRP therapies (newer injectable or oral agents that block CGRP or its receptor) versus conventional migraine preventives (antidepressants including amitriptyline, nortriptyline, and venlafaxine; antihypertensives including propranolol, verapamil, and candesartan; and the anticonvulsant topiramate). Participants are randomly assigned - like a coin flip - to one of the two treatment groups; neither group receives a placebo, as both receive active migraine treatment. The study's primary outcome is change in the Tinnitus Functional Index (TFI) over 24 weeks, with additional measures including hearing tests, balance assessments, auditory brainstem response testing, and a comprehensive symptom diary. The study is conducted at the Stanford Ear Institute and is funded by a philanthropic gift to the Department of Otolaryngology - Head \& Neck Surgery at Stanford University.
Official title: Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-07
Completion Date
2031-07
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
Galcanezumab
240 mg loading dose, then 120 mg monthly; intramuscular injection. Manufacturer: Eli Lilly.
Erenumab 70 mg
70-140 mg monthly; subcutaneous injection. Manufacturer: Amgen/Novartis.
Eptinezumab
100-300 mg every 3 months; intravenous infusion. Manufacturer: Lundbeck.
Atogepant
10, 30, or 60 mg daily; oral. Manufacturer: AbbVie.
Amitriptyline
10-100 mg daily; oral. Generic.
Nortriptyline
10-100 mg daily; oral. Generic.
propranolol
10-120 mg daily; oral. Generic.
Verapamil SR 120 mg
120-480 mg SR daily; oral. Generic.
Candesartan
2-32 mg daily; oral. Generic.
topiramate
12.5-200 mg daily; oral. Generic.