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

Sponsor
Stanford University
Study ID
NCT07655440
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Migraine
  • Migraine Associated Vertigo
  • Tinnitus
  • Vestibular Migraine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Galcanezumab — DRUG
    240 mg loading dose, then 120 mg monthly; intramuscular injection. Manufacturer: Eli Lilly.
  • Erenumab 70 mg — DRUG
    70-140 mg monthly; subcutaneous injection. Manufacturer: Amgen/Novartis.
  • Eptinezumab — DRUG
    100-300 mg every 3 months; intravenous infusion. Manufacturer: Lundbeck.
  • Atogepant — DRUG
    10, 30, or 60 mg daily; oral. Manufacturer: AbbVie.
  • Amitriptyline — DRUG
    10-100 mg daily; oral. Generic.
  • Nortriptyline — DRUG
    10-100 mg daily; oral. Generic.
  • propranolol — DRUG
    10-120 mg daily; oral. Generic.
  • Verapamil SR 120 mg — DRUG
    120-480 mg SR daily; oral. Generic.
  • Candesartan — DRUG
    2-32 mg daily; oral. Generic.
  • topiramate — DRUG
    12.5-200 mg daily; oral. Generic.

Study Details

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.

Key Dates

First listed
Jun 17, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CGRP-Targeting Therapy
    Participants assigned to this arm receive one CGRP-targeting migraine preventive agent selected by the treating clinician based on clinical appropriateness and patient factors. Options include anti-CGRP monoclonal antibodies (galcanezumab, erenumab, fremanezumab, eptinezumab) or gepants (atogepant, rimegepant). Treatment duration is 24 weeks.
  • Active Comparator: Conventional Migraine Preventive Therapy
    Participants assigned to this arm receive one conventional migraine preventive agent selected by the treating clinician based on clinical appropriateness and patient factors. Options are organized by class: antidepressants (amitriptyline, nortriptyline, venlafaxine), antihypertensives (propranolol, verapamil, candesartan), or anticonvulsants (topiramate). Treatment duration is 24 weeks.

Primary Outcome Measure

Change in Tinnitus Functional Index (TFI) Score [ Time Frame: Baseline to 24 weeks ]

Central Contacts

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