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Tricyclic Antidepressant

Amitriptyline for Migraine (RCTVM Trial)

Phase < 1
Waitlist Available
Led By Richard A Roberts, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English-speaking adults
Diagnosed with Definite Vestibular Migraine
Must not have
Already using amitriptyline
Non-English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 60, 90 days and 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the effects of amitriptyline medication and lifestyle modifications on reducing symptoms of dizziness and headache in patients with vestibular migraine. The study will randomly assign participants to either

Who is the study for?
This trial is for individuals who experience vestibular migraine, which includes symptoms like vertigo, nausea, and balance issues. Participants must be diagnosed with VM to join the study. The trial will involve a random assignment to either take the medication Amitriptyline or engage in lifestyle modifications.
What is being tested?
The study aims to compare the effectiveness of Amitriptyline against lifestyle changes in reducing dizziness and headache symptoms associated with vestibular migraine. Progress will be tracked using specific inventories for dizziness (DHI) and headaches (HDI), at intervals up to one year.
What are the potential side effects?
Amitriptyline may cause side effects such as dry mouth, constipation, blurred vision, sleepiness, weight gain or loss, and potentially more serious heart-related issues. Lifestyle modification typically has fewer risks but may include challenges adapting new habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult who speaks English.
Select...
I have been diagnosed with vestibular migraine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking amitriptyline.
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I do not speak English.
Select...
I am currently being treated for Meniere's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30, 60, 90 days and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 60, 90 days and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Dizziness
Change in Headache
Side Effects

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Lifestyle ModificationActive Control1 Intervention
Written and video instructions to help improve restful sleep, mealtime regularity, avoidance of dietary triggers, and exercise for 90 days.
Group II: AmitriptylineActive Control1 Intervention
amitriptyline, tablet, 25 mg, once daily, 90 days

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
903 Previous Clinical Trials
938,476 Total Patients Enrolled
1 Trials studying Migraine
Richard A Roberts, PhDPrincipal InvestigatorVanderbilt University Medical Center
~67 spots leftby Jun 2026
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