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

15. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Tinnitus Functional Index (TFI) Score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Tinnitus Functional Index (TFI) Score at 12 Weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Hyperacusis Questionnaire (HQ) Score
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stanford University

Ermittler

  • Hauptermittler: Kristen K. Steenerson, Stanford University
  • Hauptermittler: Matthew Fitzgerald, Stanford University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2031

Studienabschluss (Geschätzt)

1. Juli 2031

Studienanmeldedaten

Zuerst eingereicht

29. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB Protocol #86437

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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