Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine

NCT06417684 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 240605
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vestibular

Outcome Measures

Primary Outcomes (3)

• Change in Dizziness

  We will measure for change in dizziness using the Dizziness Handicap Inventory (DHI)

  Baseline DHI pre-intervention, 30, 60, 90 days and 1 year.

• Change in Headache

  We will measure for change in headache using the Headache Disability Inventory Inventory (HDI)

  Baseline HDI pre-intervention, 30, 60, 90 days and 1 year.

• Side Effects

  Participants will tabulate the rates of any reported side effects

  30, 60, 90 days and 1 year

Study Arms (2)

Amitriptyline

ACTIVE COMPARATOR

amitriptyline, tablet, 25 mg, once daily, 90 days

Drug: Amitriptyline

Lifestyle Modification

ACTIVE COMPARATOR

Written and video instructions to help improve restful sleep, mealtime regularity, avoidance of dietary triggers, and exercise for 90 days.

Behavioral: Lifestyle Modification

Interventions

Amitriptyline DRUG

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

Amitriptyline

Lifestyle Modification BEHAVIORAL

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

Lifestyle Modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking adults
• Diagnosed with Definite Vestibular Migraine
• Currently prescribed rescue medication for migraine is acceptable

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Amitriptyline

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Richard A Roberts, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: June 19, 2024
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)