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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years or older

Non-pulsatile, subjective tinnitus present for at least 6 months

Tinnitus Functional Index (TFI) score greater than 25 at screening, indicating at least mild-to-moderate tinnitus burden

Current or past history of migraine, vestibular migraine, or episodic headache disorder, diagnosed by a physician or meeting ICHD-3 criteria

Disqualifiers

Pulsatile tinnitus or objective tinnitus (tinnitus audible to examiner)

Pregnancy, planned pregnancy during the study period, or breastfeeding

Participation in any other interventional tinnitus treatment research protocol during the study period

Currently receiving a CGRP-targeting medication (for participants being considered for the conventional arm) or a conventional migraine preventive medication listed in this protocol (for participants being considered for the CGRP arm) - to avoid within-arm ineligibility at randomization

Trial design

Treatments tested in this trial

  • Galcanezumab
  • Erenumab 70 mg
  • Eptinezumab
  • Atogepant
  • Amitriptyline
  • Nortriptyline
  • propranolol
  • Verapamil SR 120 mg
  • Candesartan
  • topiramate

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators