Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine
Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 11, 2024
Trial Information
Current as of October 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is testing two ways to help people with vestibular migraine, a condition that can cause vertigo, dizziness, and headaches. In a random assignment, adults will either take a daily 25 mg dose of amitriptyline (a medication) at night for 90 days or follow a structured lifestyle program for 90 days that focuses on better sleep, regular mealtimes, avoiding triggers, and regular exercise. Researchers will measure changes in dizziness and headache using two simple questionnaires at baseline, 30, 60, 90 days, and again at 1 year. Results aren’t available yet, and about 100 participants are planned to enroll at Vanderbilt University Medical Center in Nashville.
To join, you’d need to be 18 or older, English-speaking, and diagnosed with definite vestibular migraine. You may still use rescue migraine medicine. Exclusions include not speaking English, active Meniere’s disease, already using amitriptyline, pregnancy, certain heart, liver, kidney, or other health issues, and some medication or safety concerns. If you participate, you’ll either take amitriptyline every evening for 90 days or follow the lifestyle plan, with regular check-ins and side effect monitoring (especially for those taking the medication). The study is still enrolling, with completion expected in 2026.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • English-speaking adults
- • Diagnosed with Definite Vestibular Migraine
- • Currently prescribed rescue medication for migraine is acceptable
- Exclusion Criteria:
- • Non-English speaking
- • Diagnosed and undergoing treatment for active Definite Meniere's disease
- • Already using amitriptyline
- * Contraindicated for intervention with amitriptyline including:
- • Patients with Hepatic Impairment
- • Patients with Renal Impairment
- • Pregnancy
- • Breastfeeding
- • Elderly Patients
- • Allergy to amitriptyline
- • Heart attack
- • Used an MAO inhibitor in the past 14 days
- • Used an "SSRI" antidepressant in the past 5 weeks
- • Bipolar disorder (manic-depression) or schizophrenia
- • Mental illness or psychosis
- • Stroke
- • Seizures
- • Diabetes
- • Glaucoma
- • Problems with urination
About Vanderbilt University Medical Center
Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Patients applied
Trial Officials
Richard A Roberts, PhD
Principal Investigator
Vanderbilt University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported