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Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine

NCT06417684 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2026-03-31

No results posted yet for this study

Summary

Vestibular migraine (VM) is one of the most common causes of vertigo attacks, affecting 1 - 5% of people. People with vestibular migraine have lower quality of life compared to others and some may experience completely debilitating symptoms. Symptoms include vertigo, nausea, head motion-induced dizziness, unsteadiness, balance problems, and lightheadedness. There is evidence the medication amitriptyline in isolation and also our lifestyle modification intervention in isolation can each help reduce symptoms of dizziness and headache in patients with VM. However, these data are observational and subject to various types of bias. The purpose of the current investigation is to determine outcomes from each intervention using randomized allocation of participants diagnosed with VM into either the amitriptyline arm or the lifestyle modification arm. The investigators will measure for change in dizziness using the Dizziness Handicap Inventory (DHI) and for change in headache using the Headache Disability Inventory (HDI). For participants in the lifestyle modification arm, the investigators will also measure for change in lifestyle factor to determine improvement on those intervention factors. Measures will be obtained pre-intervention to establish baseline, at 30 days, 60 days, and 90 days. the investigators will also re-survey participants one year after initiation of intervention to determine adherence and status.

Conditions

  • Vestibular Migraine

Interventions

DRUG

Amitriptyline

25 mg prescribed to be taken once daily for 90 days each evening.

BEHAVIORAL

Lifestyle Modification

Written and video instructions to instruct the participant to improve restful sleep, exercise, avoidance of dietary triggers, and mealtime regularity.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Richard A Roberts, PhD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2026-03-11
Completion
2026-03-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06417684 on ClinicalTrials.gov