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NCT04417361 · ClinicalTrials.gov registry record · Phase 2

Galcanezumab for Vestibular Migraine

A Phase 2 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT04417361: Completed Phase 2 study, sponsored by University of California, San Francisco.

NCT04417361 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04417361, a Phase 2 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult population of the United States. Yet, despite its high prevalence, there is very little data upon which to guide treatment decisions. A Cochrane review in 2015 concluded that there were no placebo controlled trials in VM, and none have been done since then. The investigators recently developed and validated a patient reported outcome tool for VM called VM-PATHI (VM- Patient Assessment Tool and Handicap Inventory). Anecdotal evidence suggests that CGRP antagonists, such as Galcanezumab, may be effective in reducing or eliminating symptoms in VM. Therefore, the investigators propose a pilot study of changes in VM-PATHI scores, comparing active treatment (Galcanezumab) to placebo arms.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Galcanezumab Prefilled Syringe

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-09-18
Est. Completion 2023-09-29
Phase Phase 2

What the finished NCT04417361 record still lists

NCT04417361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04417361 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04417361 about?

NCT04417361 is a clinical study titled "Galcanezumab for Vestibular Migraine". Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult populatio...

What is the current status of trial NCT04417361?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-09-18. Estimated completion is 2023-09-29.

What interventions are being tested in trial NCT04417361?

The interventions under investigation include: Placebo (DRUG), Galcanezumab Prefilled Syringe (DRUG).

Who is sponsoring clinical trial NCT04417361?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04417361's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04417361, the US trial registry maintained by the National Library of Medicine. NCT04417361 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.