Galcanezumab for Vestibular Migraine

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Eli Lilly and Company
• Treatments: Erenumab

Criteria

Inclusion Criteria:

1. Male or female aged 18 to 75 years of age at Study Visit 1.

2. 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

3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

4. Baseline and Study Visit 2 VM-PATHI score > 25

5. Baseline (month 0 to 1) definite dizzy days > 4

6. Fluency in English

7. 80% adherence or better to daily text message during baseline phase

8. Written informed consent

9. Access to email, and cell phone

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to use approved form of birth control during participation in the study.

2. 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.

3. Allergy to galcanezumab

4. Prior treatment with galcanezumab

5. History of ear surgery (other than ear tubes)

6. 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.

7. Failure of treatment with > 4 prophylactic migraine medications

8. Prior or current treatment with a CGRP medication

9. Pregnant/breastfeeding if female

10. 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)

11. History of mania, psychosis, or suicidal ideations

12. Ok if on up to 2 migraine prophylactic medications (prescribed for that purpose), dose must be stable for 2 months prior to study start.