Vestibular Migraine: Less Dizziness With Galcanezumab


TOPLINE:

Galcanezumab was associated with significantly less dizziness in patients with vestibular migraine (VM) compared with placebo, suggests new results from the first randomized clinical trial in VM.

METHODOLOGY:

  • The INVESTMENT study was a single-site, double-blind, placebo-controlled randomized clinical trial with 40 participants (mean age, 51 years; 75% women) with a diagnosis of VM or probable VM as per the Bárány Society criteria.
  • Participants subcutaneously received either galcanezumab (n = 18) or placebo (n = 22) for 3 months, with dosages of 240 mg in the first month and 120 mg in both the second and third months.
  • The primary outcome was the change in VM Patient Assessment Tool and Handicap Inventory (VM-PATHI) score from baseline to month 4.
  • Secondary outcomes included the change in Dizziness Handicap Inventory (DHI) score from baseline to month 4 and the reduction in the count of definite dizzy days (DDDs) per month from baseline to month 4.

TAKEAWAY:

  • Galcanezumab was associated with significantly reduced VM-PATHI scores (−14.8 points vs −5.1 points; = .044) and DHI scores by (−22.0 points vs −8.3 points; P = .018) compared with placebo.
  • The decrease in DDDs per month from baseline to month 4 was significantly greater with galcanezumab than with placebo (63% vs 31% in the third month of treatment; P = .026).
  • The galcanezumab group reported greater reductions in both mental and physical subscales of the PROMIS Global Health v1.2, although the differences were not statistically significant.
  • No serious adverse events were reported during the study.

IN PRACTICE:

“VM is one of the most common causes of dizziness and vertigo, if not the most common. Despite that, there is evidence of underdiagnosis, and many patients and providers lack understanding of this disease,” the authors wrote. “In this study, we found that galcanezumab outperformed placebo in the treatment of VM across multiple outcomes. These changes are clinically meaningful, exceeding the minimal clinically important difference for each measure used.”

SOURCE:

The study was led by Jeffrey D. Sharon, MD, University of California, San Francisco. It was published online on September 30 in Headache.

LIMITATIONS: 

The study was prematurely terminated due to the sponsor stopping the supply of galcanezumab and placebo, affecting the sample size. An error from the study pharmacist led to two participants being accidentally crossed over from the placebo to the galcanezumab arm. The small-scale, single-center design may have limited the generalizability of the findings. Pre- and post-intervention vestibular testing was not systematically obtained, which could have provided insights into the mechanism of action of calcitonin gene-related peptides against VM.

DISCLOSURES:

The study was funded by Eli Lilly and Company. One author reported receiving research support from Eli Lilly and Company and additional research funding from Advanced Bionics. He also reported advisory and employment ties with two sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.



Source link : https://www.medscape.com/viewarticle/vestibular-migraine-less-dizziness-galcanezumab-2024a1000j30?src=rss

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Publish date : 2024-10-18 12:44:47

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