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Monoclonal Antibodies
Galcanezumab Prefilled Syringe for Vestibular Migraine
Phase 2
Recruiting
Led By Jeffrey D Sharon, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline (month 0) to after treatment (month 4)
Awards & highlights
Summary
This trial tests Galcanezumab, a medication that blocks a migraine-causing protein, on patients with vestibular migraine who suffer from dizziness. The goal is to see if it can reduce their symptoms by stopping the protein that triggers these issues. Galcanezumab has been shown to reduce migraine headache days and improve patient functioning in previous studies.
Eligible Conditions
- Vestibular Migraine
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline (month 0) to after treatment (month 4)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline (month 0) to after treatment (month 4)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score from Baseline to Month 4
Secondary study objectives
Change in Dizziness Handicap Inventory Score from Baseline to Month 4
Change in Number of Definitive Dizzy Days for Participants Measured Daily from Baseline to Month 4 via Text Message
Change in Patient-Reported Outcomes Measurement Information System Short Form (PROMIS SF) v1.2- Global Health Scores
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GalcanezumabExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,640 Previous Clinical Trials
3,221,594 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,836 Total Patients Enrolled
Jeffrey D Sharon, MDPrincipal InvestigatorUniversity of California, San Francisco
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