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.
Timeline
- Start
- 2026-07
- Primary completion
- 2031-07
- Completion
- 2031-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |