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Vestibular MigrainePhase 2NCT04417361

Galcanezumab for Vestibular Migraine

A Phase 2 study testing Galcanezumab Prefilled Syringe in people with Vestibular Migraine, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Vestibular Migraine
What is being tested?
Galcanezumab Prefilled Syringe
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
18 Sep 2020to 29 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 18 to 75 years of age at Study Visit 1.
  • Documentation of a vestibular migraine or probable vestibular migraine diagnosis according to the following criteria determined by the Barany Society:
  • Vestibular migraine
  • A: At least 5 episodes with vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours
  • B: Current or previous history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)
  • C: One or more migraine features with at least 50% of the vestibular episodes:
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  • Headache with at least two of the following characteristics: one sided location, pulsating quality, moderate or severe pain intensity, aggravation by routine physical activity
  • Photophobia and phonophobia
  • Visual aura
  • D: Not better accounted for by another vestibular or ICHD diagnosis
  • Probable vestibular migraine
  • At least 5 episodes with vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours
  • Only one of the criteria B and C for vestibular migraine is fulfilled (migraine history or migraine features during the episode)
  • Not better accounted for by another vestibular or ICHD diagnosis
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  • Baseline and Study Visit 2 VM-PATHI score > 25
  • Baseline (month 0 to 1) definite dizzy days > 4
  • Fluency in English
  • 80% adherence or better to daily text message during baseline phase
  • Written informed consent
  • Access to email, and cell phone

Who cannot join

  • Pregnant, breastfeeding, or unwilling to use approved form of birth control during participation in the study.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Allergy to galcanezumab
  • Prior treatment with galcanezumab
  • History of ear surgery (other than ear tubes)
  • Other vestibular diagnosis (excluding treated Benign Paroxysmal Positional Vertigo- BPPV). This includes Meniere's disease, superior canal dehiscence syndrome, vestibular neuritis, persistent postural perceptual dizziness, unilateral or bilateral vestibular loss, cerebellar or brainstem disease, multiple sclerosis, or Mal de Debarquement.
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  • Failure of treatment with > 4 prophylactic migraine medications
  • Prior or current treatment with a CGRP medication
  • Pregnant/breastfeeding if female
  • History of serious medical or psychiatric disease, at the discretion of the treating physician (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, Raynaud's disease, uncontrolled psychiatric disease or past psychiatric hospitalization)
  • History of mania, psychosis, or suicidal ideations
  • Ok if on up to 2 migraine prophylactic medications (prescribed for that purpose), dose must be stable for 2 months prior to study start.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Medical Center at Mount Zion

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Pilot Trial of Galcanezumab for Vestibular Migraine

Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult population of the United States. Yet, despite its high prevalence, there is very little data upon which to guide treatment decisions. A Cochrane review in 2015 concluded that there were no placebo controlled trials in VM, and none have been done since then. The investigators recently developed and validated a patient reported outcome tool for VM called VM-PATHI (VM- Patient Assessment Tool and Handicap Inventory). Anecdotal evidence suggests that CGRP antagonists, such as Galcanezumab, may be effective in reducing or eliminating symptoms in VM. Therefore, the investigators propose a pilot study of changes in VM-PATHI scores, comparing active treatment (Galcanezumab) to placebo arms.

Read the detailed description

Vestibular migraine (VM) is a distinct subtype of migraine that causes episodic vertigo/dizziness, sometimes with headache, and sometimes without. However, unlike traditional migraines, patients generally seek out care because of dizziness, and not because of headache. Therefore, these patients are cared for by a variety of providers who treat dizziness, including otolaryngologists and neurologists. Lifetime prevalence of VM in the general population is estimated to be 2.7%, and at least 10% of patients in a tertiary care vestibular clinic have VM. Furthermore, VM has been shown to decrease quality of life in multiple domains, including overall health, mental health, and emotional health. Since testing and imaging are usually normal, diagnosis can only be made on clinical grounds. Recently, consensus criteria for diagnosis was published by the Barany Society and the International Classification of Headache Disorders.

Galcanezumab is a calcitonin gene related peptide (CGRP) antagonist that has been approved by the FDA for treatment of episodic and chronic migraine. Its effects with regards to VM have not been formally studied. However, there is ample evidence to suggest that aberrant trigeminovascular inflammation may be integral to the pathophysiology of VM, similar to migraine in general.

This pilot study will be a single center, randomized double-blinded placebo-controlled trial comparing galcanezumab to placebo for treatment of VM. Screening data will be reviewed to determine subject eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Participants in the galcanezumab arm will receive 240 mg via subcutaneous injection with a pre-loaded syringe at month 1, followed by 120 mg at month 2, and 120 mg at month 3. Those in the placebo arms will receive subcutaneous injections at the same time intervals of placebo. Randomization will occur through the hospital research pharmacy. Allocation concealment will be ensured; study participants will be given an envelope from a folder of sequentially ordered identical envelopes that will contain study instructions and the allocated drug. The master file linking study ID with allocation will be created by a third party and kept secret until after data analysis is complete. This will ensure that both providers and participants are adequately blinded. Blocking will be used in increments of 10 subjects to ensure equitable distribution of subjects into the two treatment arms. In addition, stratification by sex and definite versus probable vestibular migraine status will be used to ensure equal allocation. Total duration of subject participation will be five months. Total duration of the study is expected to be 2 years.

Data collection will be performed by the clinical research coordinator during each study visit. This data will be entered into the REDCap database by the research coordinator. VM- Patient Assessment Tool and Handicap Inventory (VM-PATHI), dizziness handicap inventory (DHI), General Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Patient-Reported Outcomes Measurement Information System Short Form (PROMIS SF) v1.1- Global Health, and Headache Impact Test-6 (HIT-6) will be administered electronically via REDCap to the subject during the study visit.

There will be no stopping rules for this trial, given the short duration of the study. Each adverse effect and serious adverse effect will be reviewed by the data safety monitoring team, and subjects may be unblinded and/or the study will be stopped early for serious safety concerns.

Being tested
Galcanezumab Prefilled Syringe, Placebo
Keywords
vestibular migraine, galcanezumab, clinical trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Galcanezumab Prefilled SyringeDrug

    Also called Emgality

    Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.

  • PlaceboDrug

    Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.

Study groups in NCT04417361
Study groupRoleWhat they receive
GalcanezumabExperimentalThe galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Receives: Drug: Galcanezumab Prefilled Syringe
PlaceboPlacebo comparatorThe placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score From Baseline to Month 4

    This is a recently developed and validated outcome measure for vestibular migraine from the investigators. It has been shown to be highly reliable and valid, and responsive to treatment changes. At this point, it is the only disease specific outcome measure for vestibular migraine. Scores are between 0 and 100, with 100 indicating higher levels of disease related suffering.

    Measured: Change between baseline (month 1) and after treatment (month 4)

Secondary outcomes (4)

  1. Change in Number of Definitive Dizzy Days for Participants Measured Daily From Baseline to Month 4 Via Text Message

    Participants will receive a daily text message to rate their dizziness from 0 (no dizziness), 1 (mild dizziness), 2 (moderate dizziness), and 3 (severe dizziness). A score of 2 or higher will count as a definitive dizzy day.

    Measured: Change between baseline (month 0) and after treatment (month 4)

  2. Change in Response Rates as Defined by Percentage Reduction in Definitive Dizzy Days Via Text Message From Baseline to Month 4

    Response rates will be measured by the percentage of participants in each arm experiencing a 100%, 75%, 50%, 25%, 0% reduction in definitive dizzy days.

    Measured: Change between baseline (month 0) to after treatment (month 4)

  3. Change in Dizziness Handicap Inventory Score From Baseline to Month 4

    This is the most widely used measure of dizziness severity, and consists of 25 questions. Questions ask about problems related to dizziness, and are scored as no (0 points), sometimes (2 points), or always (4 points). Total score is between 0 and 100, with higher scores indicating more disability.

    Measured: Change between baseline (month 0) to after treatment (month 4)

  4. Change in Patient-Reported Outcomes Measurement Information System Short Form (PROMIS SF) v1.2- Global Health Scores

    There are 10 questions on this quality of life measure, each with a score of 1-5. Higher scores correspond to a greater extent of the concept measured (e.g., more fatigue). Two summed scores are generated, one for global mental health (question #3, 6, 7, 8) and one for global physical health (question #2, 4, 5, 10). The remaining 2 questions are analyzed separately.

    Summed scores for physical health and mental health are converted into T-score values using the "HealthMeasures Scoring Service" available online.

    The average score for the US population is 50, with a standard deviation of 10. Higher scores indicate better physical and mental health.

    Measured: Change between baseline (month 1) to after treatment (month 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start18 Sep 2020
  3. Primary completion29 Sep 2023
  4. Study completion29 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study drug will be administered with a subcutaneous injection of galcanezumab or placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will get either a subcutaneous injection of galcanezumab 120 mg or placebo. The injections will be with a pre-loaded syringe containing either galcanezumab or placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417361
Sponsor's protocol ID
19-29340
Other IDs
P0541760
Status last verified
Nov 2024
First submitted
1 Jun 2020
Last updated
10 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van Ombergen A, Van Rompaey V, Van de Heyning P, Wuyts F. Vestibular migraine in an otolaryngology clinic: prevalence, associated symptoms, and prophylactic medication effectiveness. Otol Neurotol. 2015 Jan;36(1):133-8. doi: 10.1097/MAO.0000000000000596.

    PubMed 25251304

  • Formeister EJ, Rizk HG, Kohn MA, Sharon JD. The Epidemiology of Vestibular Migraine: A Population-based Survey Study. Otol Neurotol. 2018 Sep;39(8):1037-1044. doi: 10.1097/MAO.0000000000001900.

    PubMed 30020261

  • Lempert T, Olesen J, Furman J, Waterston J, Seemungal B, Carey J, Bisdorff A, Versino M, Evers S, Newman-Toker D. Vestibular migraine: diagnostic criteria. J Vestib Res. 2012;22(4):167-72. doi: 10.3233/VES-2012-0453.

    PubMed 23142830

  • Furman JM, Marcus DA, Balaban CD. Vestibular migraine: clinical aspects and pathophysiology. Lancet Neurol. 2013 Jul;12(7):706-15. doi: 10.1016/S1474-4422(13)70107-8.

    PubMed 23769597

  • Vass Z, Dai CF, Steyger PS, Jancso G, Trune DR, Nuttall AL. Co-localization of the vanilloid capsaicin receptor and substance P in sensory nerve fibers innervating cochlear and vertebro-basilar arteries. Neuroscience. 2004;124(4):919-27. doi: 10.1016/j.neuroscience.2003.12.030.

    PubMed 15026132

  • Salviz M, Yuce T, Acar H, Karatas A, Acikalin RM. Propranolol and venlafaxine for vestibular migraine prophylaxis: A randomized controlled trial. Laryngoscope. 2016 Jan;126(1):169-74. doi: 10.1002/lary.25445. Epub 2015 Jul 30.

    PubMed 26228645

  • Reploeg MD, Goebel JA. Migraine-associated dizziness: patient characteristics and management options. Otol Neurotol. 2002 May;23(3):364-71. doi: 10.1097/00129492-200205000-00024.

    PubMed 11981397

  • Mikulec AA, Faraji F, Kinsella LJ. Evaluation of the efficacy of caffeine cessation, nortriptyline, and topiramate therapy in vestibular migraine and complex dizziness of unknown etiology. Am J Otolaryngol. 2012 Jan-Feb;33(1):121-7. doi: 10.1016/j.amjoto.2011.04.010. Epub 2011 Jun 24.

    PubMed 21704423

  • Lepcha A, Amalanathan S, Augustine AM, Tyagi AK, Balraj A. Flunarizine in the prophylaxis of migrainous vertigo: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2014 Nov;271(11):2931-6. doi: 10.1007/s00405-013-2786-4. Epub 2013 Oct 29.

    PubMed 24166742

  • Maldonado Fernandez M, Birdi JS, Irving GJ, Murdin L, Kivekas I, Strupp M. Pharmacological agents for the prevention of vestibular migraine. Cochrane Database Syst Rev. 2015 Jun 21;2015(6):CD010600. doi: 10.1002/14651858.CD010600.pub2.

    PubMed 26093662

  • Sharon JD, Krauter R, Chae R, Gardi A, Hum M, Allen I, Levin M. A placebo controlled, randomized clinical trial of galcanezumab for vestibular migraine: The INVESTMENT study. Headache. 2024 Nov-Dec;64(10):1264-1272. doi: 10.1111/head.14835. Epub 2024 Sep 30.

    PubMed 39344988

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Galcanezumab Prefilled Syringe in people with Vestibular Migraine, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score From Baseline to Month 4 (time frame: Change between baseline (month 1) and after treatment (month 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417361, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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