Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-22 @ 12:37 PM
NCT ID:
NCT04417361
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04417361
Study Brief:
Protocol Section:
NCT04417361