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

NCT ID: NCT03578354

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vestibular Migraine Migraine Disorders Vestibular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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4-AP

15 mg 4-aminopyridine twice daily

Group Type EXPERIMENTAL

4-aminopyridine

Intervention Type DRUG

an oral drug to be swallowed

Atenolol

25 mg atenolol twice daily

Group Type EXPERIMENTAL

Atenolol

Intervention Type DRUG

an oral drug to be swallowed

Placebo

Masked placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

a masked placebo to be swallowed

Interventions

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4-aminopyridine

an oral drug to be swallowed

Intervention Type DRUG

Atenolol

an oral drug to be swallowed

Intervention Type DRUG

Placebo

a masked placebo to be swallowed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Richard Lewis

Associate Professor, Otolaryngology and Neurology; Director, Jenks Vestibular Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Pending

Identifier Type: -

Identifier Source: org_study_id

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