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

15 giugno 2026 aggiornato da: Kristen K. Steenerson, MD, Stanford University

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tinnitus affects approximately 15% of the global population, and migraine history is an established risk factor for both its prevalence and severity. Converging preclinical and clinical evidence implicates calcitonin gene-related peptide (CGRP) signaling at the intersection of these two conditions: CGRP and its receptors are expressed in cochlear inner and outer hair cells, the spiral ganglion, and the vestibular end organs; in a chronic migraine mouse model, cochlear CGRP expression is upregulated and CGRP administration attenuates cochlear deficits; and in humans, conventional migraine preventive medications have been shown to reduce tinnitus burden as measured by the TFI. Whether CGRP-targeting agents confer additional or differential benefit for tinnitus - given their direct cochlear and vestibular targets - has not been evaluated in a randomized controlled trial.

COMPACT-PM addresses this gap using a randomized, open-label, active-comparator controlled design. A placebo arm is not included because withholding migraine preventive treatment from patients with a clinical indication for preventive therapy would be ethically inappropriate; both arms therefore receive active, clinically indicated migraine treatment, and randomization controls for treatment selection bias. Within each arm, the specific agent is selected by the treating clinician based on clinical appropriateness, patient factors, and insurance coverage; participants must have confirmed insurance access to at least one CGRP-targeting agent prior to randomization.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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
  • Clinically appropriate candidate for migraine preventive therapy as determined by the treating clinician
  • Stable medication regimen for at least 3 months prior to enrollment (no new medications started or stopped within 3 months of screening)
  • Ability to provide written informed consent
  • Ability to complete self-report questionnaires in English or with certified interpreter assistance
  • Willingness to attend three in-person study visits over 24 weeks and complete daily symptom diaries

Exclusion Criteria:

  • 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
  • Known contraindication to all medications within the assigned study arm
  • History of serious cardiovascular event (myocardial infarction, stroke, or unstable angina) within 6 months of enrollment
  • Severe hepatic or renal impairment that would contraindicate study medications
  • Active psychiatric disorder requiring medication adjustment within 3 months of enrollment
  • Known hypersensitivity or prior serious adverse reaction to a medication within the assigned study arm
  • Active malignancy or life expectancy less than 12 months
  • Inability to complete study procedures or follow-up visits in the judgment of the investigator

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Tinnitus Functional Index (TFI) Score
Lasso di tempo: Baseline to 24 weeks
The TFI is a validated 25-item self-report questionnaire measuring the negative impact of tinnitus on daily life. Scores range from 0-100; higher scores indicate greater tinnitus burden. The minimally important clinical difference is 13 points. The primary endpoint is the between-arm difference in TFI change from baseline to 24 weeks. The Tinnitus Functional Index (TFI) is a validated 25-item self-report questionnaire measuring the negative impact of tinnitus on daily life. Scores range from 0-100; higher scores indicate greater tinnitus burden. The minimally important clinical difference is 13 points. The primary endpoint is the between-arm difference in TFI change from baseline to 24 weeks, with a greater reduction indicating better outcome.
Baseline to 24 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Tinnitus Functional Index (TFI) Score at 12 Weeks
Lasso di tempo: Baseline to 12 weeks
Between-arm difference in TFI change from baseline to 12 weeks, to characterize early treatment response. The Tinnitus Functional Index (TFI) is a validated 25-item self-report questionnaire measuring the negative impact of tinnitus on daily life. Scores range from 0-100; higher scores indicate greater tinnitus burden. The minimally important clinical difference is 13 points. The primary endpoint is the between-arm difference in TFI change from baseline to 24 weeks, with a greater reduction indicating better outcome.
Baseline to 12 weeks
TFI Score Trajectory
Lasso di tempo: Weeks 4, 8, 16, 20
Within- and between-arm TFI change at weeks 4, 8, 16, and 20 to characterize the time course of tinnitus response. The Tinnitus Functional Index (TFI) is a validated 25-item self-report questionnaire measuring the negative impact of tinnitus on daily life. Scores range from 0-100; higher scores indicate greater tinnitus burden. The minimally important clinical difference is 13 points. The primary endpoint is the between-arm difference in TFI change from baseline to 24 weeks, with a greater reduction indicating better outcome.
Weeks 4, 8, 16, 20
Change in Tinnitus Handicap Inventory (THI) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The THI is a validated 25-item questionnaire measuring tinnitus-related handicap across functional, emotional, and catastrophic subscales. Scores range from 0-100. The Tinnitus Handicap Inventory (THI) is a validated 25-item questionnaire measuring tinnitus-related handicap across functional, emotional, and catastrophic subscales. Scores range from 0-100; higher scores indicate greater handicap and worse outcome.
Baseline, 12 weeks, 24 weeks
Change in Visual Analog Scale (VAS) Tinnitus Loudness
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Participant-rated tinnitus loudness on a 0-10 VAS, where 0 = no loudness and 10 = worst imaginable loudness.
Baseline, 12 weeks, 24 weeks
Change in Visual Analog Scale (VAS) Tinnitus Unpleasantness
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Participant-rated tinnitus unpleasantness on a 0-10 VAS, where 0 = not unpleasant and 10 = worst imaginable unpleasantness.
Baseline, 12 weeks, 24 weeks
Patient Global Impression of Change (PGIC)
Lasso di tempo: 12 weeks, 24 weeks
Single-item participant-rated global impression of change in tinnitus since starting study treatment, rated on a 7-point scale from 1 (very much worse) to 7 (very much improved).
12 weeks, 24 weeks
Change in Headache Impact Test-6 (HIT-6) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The HIT-6 is a validated 6-item questionnaire measuring the impact of headaches on daily functioning. Scores range from 36-78; higher scores indicate greater headache impact.
Baseline, 12 weeks, 24 weeks
Change in Migraine Disability Assessment (MIDAS) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The Migraine Disability Assessment (MIDAS) quantifies headache-related disability over the prior 3 months based on lost productive time, scored in days. Scores range from 0 to unlimited; higher scores indicate greater disability and worse outcome.
Baseline, 12 weeks, 24 weeks
Change in Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) is a validated 25-item patient-reported outcome measure specific to vestibular migraine, assessing symptom frequency, severity, and impact. Scores range from 0-100; higher scores indicate greater disease burden and worse outcome. Administered to all participants; subgroup analysis planned for those with confirmed vestibular migraine diagnosis.
Baseline, 12 weeks, 24 weeks
Change in Dizziness Handicap Inventory (DHI) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The Dizziness Handicap Inventory (DHI) is a validated 25-item questionnaire measuring the self-perceived handicap imposed by dizziness and unsteadiness. Scores range from 0-100; higher scores indicate greater handicap and worse outcome.
Baseline, 12 weeks, 24 weeks
Monthly Headache Days
Lasso di tempo: Baseline through 24 weeks
Number of headache days per month recorded in participant daily diary, averaged over each 4-week interval between study visits.
Baseline through 24 weeks
Monthly Dizzy Days
Lasso di tempo: Baseline through 24 weeks
Number of days with dizziness or vertigo per month recorded in participant daily diary, averaged over each 4-week interval between study visits.
Baseline through 24 weeks
Monthly Nausea Days
Lasso di tempo: Baseline through 24 weeks
Number of days with nausea per month recorded in participant daily diary, averaged over each 4-week interval between study visits.
Baseline through 24 weeks
Acute Medication Use
Lasso di tempo: Baseline through 24 weeks
Number of days per month with acute migraine or vestibular rescue medication use, recorded in participant daily diary.
Baseline through 24 weeks
Change in Pure Tone Audiometric Thresholds
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in air conduction pure tone thresholds at 250-8000 Hz from baseline, assessed by standard audiogram.
Baseline, 12 weeks, 24 weeks
Change in Speech-in-Noise Performance (QuickSIN)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in signal-to-noise ratio loss from baseline as measured by the Quick Speech-in-Noise (QuickSIN) test, reflecting auditory processing in noise.
Baseline, 12 weeks, 24 weeks
Change in Auditory Brainstem Response (ABR)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in ABR wave latencies and amplitudes from baseline, reflecting peripheral and central auditory pathway integrity.
Baseline, 12 weeks, 24 weeks
Change in Tinnitus Pitch and Loudness Characteristics
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in psychoacoustic tinnitus pitch match (Hz) and loudness match (dB SL) from baseline.
Baseline, 12 weeks, 24 weeks
Change in Video Head Impulse Test (vHIT)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in semicircular canal vestibulo-ocular reflex (VOR) gain and saccades from baseline, assessed by vHIT across all six semicircular canals.
Baseline, 12 weeks, 24 weeks
Rotary Chair - VOR Gain
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in vestibulo-ocular reflex (VOR) gain from baseline, assessed by sinusoidal harmonic acceleration rotary chair testing across multiple frequencies. Gain is a unitless ratio (eye velocity / chair velocity); values closer to 1.0 indicate better vestibular function.
Baseline, 12 weeks, 24 weeks
Change in Cervical and Ocular Vestibular Evoked Myogenic Potentials (cVEMP/oVEMP)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in cVEMP and oVEMP amplitude, threshold, and latency from baseline, reflecting saccular, utricular, and inferior/superior vestibular nerve function.
Baseline, 12 weeks, 24 weeks
VNG - Ocular Motor Testing
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Change in ocular motor parameters from baseline assessed by videonystagmography (VNG), including gaze stability, saccade accuracy and latency, smooth pursuit gain, and optokinetic response gain. Each parameter is reported in its respective unit (degrees/second, milliseconds, or unitless ratio); values will be analyzed individually.
Baseline, 12 weeks, 24 weeks
Adverse Event Rate
Lasso di tempo: Baseline through 24 weeks plus 30-day safety follow-up
Frequency and severity of adverse events and serious adverse events in each arm, assessed throughout the study period and graded by CTCAE criteria.
Baseline through 24 weeks plus 30-day safety follow-up
TFI Responder Rate
Lasso di tempo: 24 weeks
Proportion of participants in each arm achieving a clinically meaningful reduction of 13 or more points from baseline on the Tinnitus Functional Index (TFI) at 24 weeks, representing the minimum important clinical difference established by Meikle et al. (2012).
24 weeks
Rotary Chair - VOR Phase
Lasso di tempo: Time Frame: Baseline, 12 weeks, 24 weeks
Change in vestibulo-ocular reflex (VOR) phase lead from baseline, assessed by sinusoidal harmonic acceleration rotary chair testing. Phase is reported in degrees; lower phase lead at low frequencies indicates better vestibular compensation.
Time Frame: Baseline, 12 weeks, 24 weeks
Rotary Chair - VOR Symmetry
Lasso di tempo: Time Frame: Baseline, 12 weeks, 24 weeks
Change in vestibulo-ocular reflex (VOR) directional preponderance/symmetry from baseline, assessed by sinusoidal harmonic acceleration rotary chair testing. Symmetry is reported as a percentage asymmetry; values closer to 0% indicate better symmetry.
Time Frame: Baseline, 12 weeks, 24 weeks
VNG - Positional and Positioning Nystagmus
Lasso di tempo: Time Frame: Baseline, 12 weeks, 24 weeks
Change in nystagmus slow-phase velocity (SPV) from baseline during positional and positioning maneuvers assessed by videonystagmography (VNG). SPV is reported in degrees/second; lower values indicate less nystagmus.
Time Frame: Baseline, 12 weeks, 24 weeks
VNG - Caloric Testing
Lasso di tempo: Time Frame: Baseline, 12 weeks, 24 weeks
Change in unilateral weakness and directional preponderance from baseline assessed by caloric irrigation during videonystagmography (VNG). Unilateral weakness and directional preponderance are reported as percentages; values closer to 0% indicate better symmetry.
Time Frame: Baseline, 12 weeks, 24 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Hyperacusis Questionnaire (HQ) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The Hyperacusis Questionnaire (HQ) is a 14-item questionnaire measuring hyperacusis severity and impact. Scores range from 0-42; higher scores indicate greater hyperacusis severity and worse outcome. Included as an exploratory outcome given the frequent co-occurrence of hyperacusis and tinnitus in this population.
Baseline, 12 weeks, 24 weeks
Pupillometry Changes
Lasso di tempo: Baseline, 12 weeks, 24 weeks

Change in sound-evoked pupil dilation amplitude and latency from baseline, as a measure of olivocochlear and autonomic auditory pathway function. Change in resting pupil diameter from baseline as a measure of baseline autonomic tone.

Exploratory mechanistic outcome.
Baseline, 12 weeks, 24 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Stanford University

Investigatori

  • Investigatore principale: Kristen K. Steenerson, Stanford University
  • Investigatore principale: Matthew Fitzgerald, Stanford University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 luglio 2031

Completamento dello studio (Stimato)

1 luglio 2031

Date di iscrizione allo studio

Primo inviato

29 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB Protocol #86437

Piano per i dati dei singoli partecipanti (IPD)

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Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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