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Galcanezumab Prefilled Syringe

Phase 2

Vestibular Migraine | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Dec 10, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04417361Galcanezumab for Vestibular MigrainePHASE2 COMPLETED 40 — — Sep 18, 2020Sep 29, 2023Dec 10, 20241 United States
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Study Endpoints
Primary Endpoints
Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score From Baseline to Month 4
Change between baseline (month 1) and after treatment (month 4)

This is a recently developed and validated outcome measure for vestibular migraine from the investigators. It has been shown to be highly reliable and valid, and responsive to treatment changes. At this point, it is the only disease specific outcome measure for vestibular migraine. Scores are between 0 and 100, with 100 indicating higher levels of disease related suffering.

Secondary Endpoints
Change in Number of Definitive Dizzy Days for Participants Measured Daily From Baseline to Month 4 Via Text Message
Change between baseline (month 0) and after treatment (month 4)
Change in Response Rates as Defined by Percentage Reduction in Definitive Dizzy Days Via Text Message From Baseline to Month 4
Change between baseline (month 0) to after treatment (month 4)
Change in Dizziness Handicap Inventory Score From Baseline to Month 4
Change between baseline (month 0) to after treatment (month 4)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GalcanezumabEXPERIMENTALThe 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.
PlaceboPLACEBO_COMPARATORThe 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.
Interventions
NameTypeDescription
Galcanezumab Prefilled SyringeDRUGGalcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
PlaceboDRUGPlacebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or female aged 18 to 75 years of age at Study Visit 1. 2. 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 ...

Countries:United States
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