Galcanezumab for Vestibular Migraine

NCT04417361 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 19-29340P0541760
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vestibular Migraine

Keywords

vestibular migraine; galcanezumab; clinical trial

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

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

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

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

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

• Change in Dizziness Handicap Inventory Score From Baseline to Month 4

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

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

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

Study Arms (2)

Galcanezumab

EXPERIMENTAL

The 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.

Drug: Galcanezumab Prefilled Syringe

Placebo

PLACEBO COMPARATOR

The 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.

Drug: Placebo

Interventions

Galcanezumab Prefilled Syringe DRUG

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.

Also known as: Emgality

Galcanezumab

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

UCSF Medical Center at Mount Zion

San Francisco, California, 94115, United States

Location

Related Publications (11)

• 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.

  PMID: 25251304 BACKGROUND

• 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.

  PMID: 30020261 BACKGROUND

• 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.

  PMID: 23142830 BACKGROUND

• 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.

  PMID: 23769597 BACKGROUND

• 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.

  PMID: 15026132 BACKGROUND

• 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.

  PMID: 26228645 BACKGROUND

• 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.

  PMID: 11981397 BACKGROUND

• 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.

  PMID: 21704423 BACKGROUND

• 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.

  PMID: 24166742 BACKGROUND

• 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.

  PMID: 26093662 BACKGROUND

• 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.

  PMID: 39344988 RESULT

MeSH Terms

Interventions

erenumab

Results Point of Contact

• Title: Jeffrey D. Sharon
• Organization: UCSF

jeffrey.sharon@ucsf.edu

4153532757

Study Officials

• Jeffrey D Sharon, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The following study procedures will be in place to ensure double-blind administration of study treatments. Access to the randomization code will be strictly controlled and this will reside with our pharmacist, who will not be blinded. All members of the clinical team and biostatistician will be blinded. Packaging and labeling of test and control treatments will be identical to maintain the blind. Each participant will be given an identical study packet, containing their assigned drug and study information. The study blind will be broken on completion of the clinical study and after the study database has been locked. Investigators will be made aware of their participants' treatment designations only after all the data has been collected and analyzed. During the study, the blind may be broken only in emergencies when knowledge of the participant's treatment group is necessary for further clinical management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: September 18, 2020
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)