Galcanezumab Prefilled Syringe for 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)

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

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)

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

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 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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