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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

Study Summary

This trial is testing whether Galcanezumab, a drug used to treat migraines, can also help treat vestibular migraines. Vestibular migraines are a type of migraine that mainly causes dizziness.

Eligible Conditions
  • Vestibular Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline (month 0) to after treatment (month 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline (month 0) to after treatment (month 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score from Baseline to Month 4
Secondary outcome measures
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 more

Trial 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
2,624 Previous Clinical Trials
3,216,871 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,517 Previous Clinical Trials
15,240,979 Total Patients Enrolled
Jeffrey D Sharon, MDPrincipal InvestigatorUniversity of California, San Francisco
~11 spots leftby Jun 2025
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