Comparing Migraine Preventive Therapies vs. Anti-CGRP Therapies for Tinnitus in Patients With Migraine (COMPACT-PM)

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.

Conditions

• Migraine Associated Vertigo
• Tinnitus
• Migraine
• Vestibular Migraine

Interventions

DRUG

Galcanezumab

240 mg loading dose, then 120 mg monthly; intramuscular injection. Manufacturer: Eli Lilly.

DRUG

Erenumab 70 mg

70-140 mg monthly; subcutaneous injection. Manufacturer: Amgen/Novartis.

DRUG

Eptinezumab

100-300 mg every 3 months; intravenous infusion. Manufacturer: Lundbeck.

DRUG

Atogepant

10, 30, or 60 mg daily; oral. Manufacturer: AbbVie.

DRUG

Amitriptyline

10-100 mg daily; oral. Generic.

DRUG

Nortriptyline

10-100 mg daily; oral. Generic.

DRUG

propranolol

10-120 mg daily; oral. Generic.

DRUG

Verapamil SR 120 mg

120-480 mg SR daily; oral. Generic.

DRUG

Candesartan

2-32 mg daily; oral. Generic.

DRUG

topiramate

12.5-200 mg daily; oral. Generic.

Sponsors & Collaborators

• Stanford University

  lead OTHER

Principal Investigators

• Kristen K. Steenerson · Stanford University

• Matthew Fitzgerald · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2031-07-31

Completion

2031-07-31

FDA Drug

Yes