Status:
COMPLETED
Galcanezumab for Vestibular Migraine
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Vestibular Migraine
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 e...
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 gener...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04417361
Start Date
September 18 2020
End Date
September 29 2023
Last Update
December 10 2024
Active Locations (1)
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1
UCSF Medical Center at Mount Zion
San Francisco, California, United States, 94115