drugset / Trial / NCT07655440

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

NCT07655440

Phase 4 Not yet recruiting 120 enrolled Stanford University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-07
Primary completion
2031-07
Completion
2031-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amitriptyline Small molecule 10 mg Oral
Comparator Amitriptyline Small molecule 100 mg Oral
Subject Atogepant Small molecule 10 mg Oral
Subject Atogepant Small molecule 30 mg Oral
Subject Atogepant Small molecule 60 mg Oral
Comparator Candesartan Unknown 2 mg Oral
Comparator Candesartan Unknown 32 mg Oral
Subject Eptinezumab Monoclonal antibody 100 mg Intravenous
Subject Eptinezumab Monoclonal antibody 300 mg Intravenous
Subject Erenumab Monoclonal antibody 70 mg Subcutaneous
Subject Erenumab Monoclonal antibody 140 mg Subcutaneous
Subject Galcanezumab Monoclonal antibody 120 mg Intramuscular
Comparator Nortriptyline Small molecule 10 mg Oral
Comparator Nortriptyline Small molecule 100 mg Oral
Comparator Propranolol Small molecule 10 mg Oral
Comparator Propranolol Small molecule 120 mg Oral
Comparator Topiramate Small molecule 12.5 mg Oral
Comparator Topiramate Small molecule 200 mg Oral
Comparator Verapamil Other / unclassified 120 mg Oral
Comparator Verapamil Other / unclassified 480 mg Oral