Comparing Migraine Preventive Therapies vs. Anti-CGRP Therapies for Tinnitus in Patients With Migraine (COMPACT-PM) (COMPACT-PM)
2026년 6월 15일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
120
단계
- 4단계
연락처 및 위치
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연구 연락처
- 이름: Jwala P Rejimon, AuD
- 전화번호: 650-736-2354
- 이메일: jrejimon@stanford.edu
연구 연락처 백업
- 이름: Research Coordinator
- 이메일: traneric@stanford.edu
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
240 mg loading dose, then 120 mg monthly; intramuscular injection.
Manufacturer: Eli Lilly.
70-140 mg monthly; subcutaneous injection.
Manufacturer: Amgen/Novartis.
100-300 mg every 3 months; intravenous infusion.
Manufacturer: Lundbeck.
10, 30, or 60 mg daily; oral.
Manufacturer: AbbVie.
|
|
활성 비교기: 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.
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10-100 mg daily; oral.
Generic.
10-100 mg daily; oral.
Generic.
10-120 mg daily; oral.
Generic.
120-480 mg SR daily; oral.
Generic.
2-32 mg daily; oral. Generic.
12.5-200 mg daily; oral.
Generic.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Tinnitus Functional Index (TFI) Score
기간: 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.
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Baseline to 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Tinnitus Functional Index (TFI) Score at 12 Weeks
기간: Baseline to 12 weeks
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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.
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Baseline to 12 weeks
|
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TFI Score Trajectory
기간: Weeks 4, 8, 16, 20
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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.
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Weeks 4, 8, 16, 20
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Change in Tinnitus Handicap Inventory (THI) Score
기간: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Change in Visual Analog Scale (VAS) Tinnitus Loudness
기간: Baseline, 12 weeks, 24 weeks
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Participant-rated tinnitus loudness on a 0-10 VAS, where 0 = no loudness and 10 = worst imaginable loudness.
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Baseline, 12 weeks, 24 weeks
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Change in Visual Analog Scale (VAS) Tinnitus Unpleasantness
기간: Baseline, 12 weeks, 24 weeks
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Participant-rated tinnitus unpleasantness on a 0-10 VAS, where 0 = not unpleasant and 10 = worst imaginable unpleasantness.
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Baseline, 12 weeks, 24 weeks
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Patient Global Impression of Change (PGIC)
기간: 12 weeks, 24 weeks
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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).
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12 weeks, 24 weeks
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Change in Headache Impact Test-6 (HIT-6) Score
기간: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Change in Migraine Disability Assessment (MIDAS) Score
기간: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Change in Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) Score
기간: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Change in Dizziness Handicap Inventory (DHI) Score
기간: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Monthly Headache Days
기간: Baseline through 24 weeks
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Number of headache days per month recorded in participant daily diary, averaged over each 4-week interval between study visits.
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Baseline through 24 weeks
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Monthly Dizzy Days
기간: Baseline through 24 weeks
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Number of days with dizziness or vertigo per month recorded in participant daily diary, averaged over each 4-week interval between study visits.
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Baseline through 24 weeks
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Monthly Nausea Days
기간: Baseline through 24 weeks
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Number of days with nausea per month recorded in participant daily diary, averaged over each 4-week interval between study visits.
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Baseline through 24 weeks
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Acute Medication Use
기간: Baseline through 24 weeks
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Number of days per month with acute migraine or vestibular rescue medication use, recorded in participant daily diary.
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Baseline through 24 weeks
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Change in Pure Tone Audiometric Thresholds
기간: Baseline, 12 weeks, 24 weeks
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Change in air conduction pure tone thresholds at 250-8000 Hz from baseline, assessed by standard audiogram.
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Baseline, 12 weeks, 24 weeks
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Change in Speech-in-Noise Performance (QuickSIN)
기간: Baseline, 12 weeks, 24 weeks
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Change in signal-to-noise ratio loss from baseline as measured by the Quick Speech-in-Noise (QuickSIN) test, reflecting auditory processing in noise.
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Baseline, 12 weeks, 24 weeks
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Change in Auditory Brainstem Response (ABR)
기간: Baseline, 12 weeks, 24 weeks
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Change in ABR wave latencies and amplitudes from baseline, reflecting peripheral and central auditory pathway integrity.
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Baseline, 12 weeks, 24 weeks
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Change in Tinnitus Pitch and Loudness Characteristics
기간: Baseline, 12 weeks, 24 weeks
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Change in psychoacoustic tinnitus pitch match (Hz) and loudness match (dB SL) from baseline.
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Baseline, 12 weeks, 24 weeks
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Change in Video Head Impulse Test (vHIT)
기간: Baseline, 12 weeks, 24 weeks
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Change in semicircular canal vestibulo-ocular reflex (VOR) gain and saccades from baseline, assessed by vHIT across all six semicircular canals.
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Baseline, 12 weeks, 24 weeks
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Rotary Chair - VOR Gain
기간: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Change in Cervical and Ocular Vestibular Evoked Myogenic Potentials (cVEMP/oVEMP)
기간: Baseline, 12 weeks, 24 weeks
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Change in cVEMP and oVEMP amplitude, threshold, and latency from baseline, reflecting saccular, utricular, and inferior/superior vestibular nerve function.
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Baseline, 12 weeks, 24 weeks
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VNG - Ocular Motor Testing
기간: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Adverse Event Rate
기간: Baseline through 24 weeks plus 30-day safety follow-up
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Frequency and severity of adverse events and serious adverse events in each arm, assessed throughout the study period and graded by CTCAE criteria.
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Baseline through 24 weeks plus 30-day safety follow-up
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TFI Responder Rate
기간: 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).
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24 weeks
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Rotary Chair - VOR Phase
기간: Time Frame: Baseline, 12 weeks, 24 weeks
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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.
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Time Frame: Baseline, 12 weeks, 24 weeks
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Rotary Chair - VOR Symmetry
기간: Time Frame: Baseline, 12 weeks, 24 weeks
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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.
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Time Frame: Baseline, 12 weeks, 24 weeks
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VNG - Positional and Positioning Nystagmus
기간: Time Frame: Baseline, 12 weeks, 24 weeks
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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.
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Time Frame: Baseline, 12 weeks, 24 weeks
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VNG - Caloric Testing
기간: Time Frame: Baseline, 12 weeks, 24 weeks
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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.
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Time Frame: Baseline, 12 weeks, 24 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Hyperacusis Questionnaire (HQ) Score
기간: 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.
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Baseline, 12 weeks, 24 weeks
|
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Pupillometry Changes
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kristen K. Steenerson, Stanford University
- 수석 연구원: Matthew Fitzgerald, Stanford University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2031년 7월 1일
연구 완료 (추정된)
2031년 7월 1일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 신경학적 징후
- 뇌 질환
- 중추신경계 질환
- 신경계 질환
- 두통 장애, 원발성
- 두통 장애
- 이비인후과 질환
- 감각 장애
- 귀 질환
- 청각 장애
- 병리학적 상태, 징후 및 증상
- 징후 및 증상
- 편두통 장애
- 이명
- 유기 화학 물질
- 탄화수소
- 탄화수소, 순환
- 탄수화물
- 나프탈렌
- 다 환식 방향족 탄화수소
- 탄화수소, 방향족
- 다 환식 화합물
- 아민
- 알코올
- 페녹시 프로판올 아민
- 프로 파놀라민
- 아미노 알코올
- 프로판올
- 페네틸 아민
- 에틸 아민
- 설탕
- Dibenzocycloheptenes
- 벤조시 클로 헵 테네
- 육각형
- 단당류
- 과당
- 케토스
- 토피라메이트
- 베라파밀
- 프로프라놀롤
- 아미트립틸린
- 노르트립틸린
- eptinezumab
- atogepant
- 에레 누 맙
- 갈카네 주맙
- 칸데사르탄
기타 연구 ID 번호
- IRB Protocol #86437
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .