Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine
Key facts
- Who runs it
- Vanderbilt University Medical Center
- Where
- Nashville, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Early phase 1
- Started
- 19 Jun 2024
- Ended
- 11 Mar 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Amitriptyline
- Lifestyle Modification
- Record updated
- 31 March 2026
- Why it stopped
- Unable to gain interest among colleagues to help recruit participants.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- English-speaking adults
- Diagnosed with Definite Vestibular Migraine
- Currently prescribed rescue medication for migraine is acceptable
Who cannot take part
- Used an MAO inhibitor in the past 14 days
- Diagnosed and undergoing treatment for active Definite Meniere's disease
- Patients with Hepatic Impairment
- Patients with Renal Impairment
- Allergy to amitriptyline
- Heart attack
- Bipolar disorder (manic-depression) or schizophrenia
- Mental illness or psychosis
- Stroke
- Seizures
- Diabetes
- Non-English speaking
- Already using amitriptyline
- Contraindicated for intervention with amitriptyline including:
- Pregnancy
- Breastfeeding
- Elderly Patients
- Used an "SSRI" antidepressant in the past 5 weeks
- Glaucoma
- Problems with urination
Where in United States
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- AmitriptylineExisting treatment, for comparison
amitriptyline, tablet, 25 mg, once daily, 90 days
- Lifestyle ModificationExisting treatment, for comparison
Written and video instructions to help improve restful sleep, mealtime regularity, avoidance of dietary triggers, and exercise for 90 days.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 31 March 2026