4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine

Massachusetts Eye and Ear Infirmary

Overview

This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. Blinded study drug will be taken by mouth twice a day for 14 weeks on study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Vestibular Migraine Migraine Disorders Vestibular Diseases

Interventions

4-aminopyridineDRUG

an oral drug to be swallowed

AtenololDRUG

an oral drug to be swallowed

PlaceboOTHER

a masked placebo to be swallowed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Severe vestibular migraine (VM) Exclusion Criteria: * Neurologic or otologic disease other than VM * Psychiatric illness requiring medication * Medical illness including cancer, coronary artery or cerebrovascular disease * Known allergy to one of the test medications * Contraindication to use of one of the test medications - asthma, symptomatic hypotension, history of seizures * Taking migraine prophylactic medication or vestibular suppressants. * Pregnant or breast feeding women

Locations (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Dizziness Handicap Score

Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment

Time frame: 14 weeks

Secondary Outcomes

Change in number of dizziness episodes

Incidence of dizziness episodes will be compared pre- and post- study drug treatment

Time frame: 14 weeks

Change in motion sickness susceptibility

Motion sickness susceptibility questionnaire (MSSQ) will be compared pre- and post- study drug treatment. MSSQ is reported as a scale (0 - 100) with 0 being no or very little experience of motion sickness, and 100 being very frequent experience of motion sickness.

Time frame: 14 weeks

Change in roll tilt perceptual threshold

Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment

Time frame: 14 weeks

Change in vestibulo-ocular reflex (VOR) time constant

Standard low-frequency rotational testing to measure VOR will be compared pre- and post- study drug treatment

Time frame: 14 weeks

Change in number of migraine episodes

Incidence of migraine episodes will be compared pre- and post- study drug treatment

Time frame: 14 weeks

Change in Headache Impact Test (HIT) score

Headache Impact Test (HIT) will be compared pre- and post- study drug treatment

Time frame: 14 weeks

Data from ClinicalTrials.gov

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