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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 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

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,615 Previous Clinical Trials

3,201,008 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,503 Previous Clinical Trials

15,236,605 Total Patients Enrolled

Jeffrey D Sharon, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide figures on how many individuals are being welcomed into this investigation?

"That is correct, the online information says that this trial is still looking for patients. This clinical trial was first posted on September 18th 2020 and was updated most recently on March 21st 2022. The study is looking for 50 people to participate at 1 location."

Answered by AI

Could you please provide a rundown of other research that has been done on Galcanezumab Prefilled Syringe?

"Given that there are 6 ongoing trials and 2 in Phase 3, Galcanezumab Prefilled Syringe is currently being heavily studied. The majority of these trials are based in Brookline, Massachusetts, but there are also 330 other locations running these trials."

Answered by AI

Have similar studies been conducted before this one?

"Galcanezumab Prefilled Syringe has undergone 6 clinical trials in 11 countries and 141 cities since 2018. The first Phase 3 drug approval stage for Galcanezumab Prefilled Syringe was completed in 2018 by Eli Lilly and Company. Since then, 18250 trials have been conducted."

Answered by AI

Does this research project focus on a specific age group?

"This clinical trial's age requirements for participants are between 18 and 75 years old."

Answered by AI

Could I join this clinical trial, if I wanted to?

"This trial is looking for 50 people, aged 18-75, who currently suffer from sick headaches. In order to qualify, participants must also meet the following criteria: A) At least 5 episodes of 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), At least 5 episodes of vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours, Headache with at least two of the following characteristics: one sided location, pulsating quality, moderate or severe"

Answered by AI

Could you please summarize any risks associated with Galcanezumab Prefilled Syringe?

"Galcanezumab has been evaluated in Phase 2 clinical trials, meaning that while there is safety data, there is no information regarding the medication's efficacy."

Answered by AI

Recent research and studies

Otology & NeurotologyJournal

The Epidemiology of Vestibular Migraine: A Population-based Survey Study

Formeister, Eric J., Habib G. Rizk, Michael A. Kohn, and Jeffrey D. Sharon. 2018. “The Epidemiology of Vestibular Migraine: A Population-based Survey Study”. Otology & Neurotology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mao.0000000000001900.

The Lancet NeurologyJournal

Vestibular Migraine: Clinical Aspects and Pathophysiology

Furman, Joseph M, Dawn A Marcus, and Carey D Balaban. 2013. “Vestibular Migraine: Clinical Aspects and Pathophysiology”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(13)70107-8.

Journal of Vestibular ResearchJournal

Vestibular Migraine: Diagnostic Criteria

Lempert, Thomas, Jes Olesen, Joseph Furman, John Waterston, Barry Seemungal, John Carey, Alexander Bisdorff, Maurizio Versino, Stefan Evers, and David Newman-Toker. 2012. “Vestibular Migraine: Diagnostic Criteria”. Journal of Vestibular Research. IOS Press. doi:10.3233/ves-2012-0453.

Otology & NeurotologyJournal