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

NCT03578354 | Withdrawn Phase 2 DMC FDA Drug

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

Brief Summary

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.

Conditions

Vestibular Migraine; Migraine Disorders; Vestibular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Dizziness Handicap Score

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

  14 weeks

Secondary Outcomes (7)

• Change in number of dizziness episodes

  14 weeks

• Change in motion sickness susceptibility

  14 weeks

• Change in roll tilt perceptual threshold

  14 weeks

• Change in vestibulo-ocular reflex (VOR) time constant

  14 weeks

• Change in number of migraine episodes

  14 weeks

Study Arms (3)

4-AP

EXPERIMENTAL

15 mg 4-aminopyridine twice daily

Drug: 4-aminopyridine

Atenolol

EXPERIMENTAL

25 mg atenolol twice daily

Drug: Atenolol

Placebo

PLACEBO COMPARATOR

Masked placebo twice daily

Other: Placebo

Interventions

4-aminopyridine DRUG

an oral drug to be swallowed

4-AP

Atenolol DRUG

an oral drug to be swallowed

Atenolol

Placebo OTHER

a masked placebo to be swallowed

Placebo

Eligibility Criteria

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

You may qualify if:

• Severe vestibular migraine (VM)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Vestibular Diseases

Interventions

4-Aminopyridine; Atenolol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Otolaryngology and Neurology; Director, Jenks Vestibular Laboratory

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 6, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: August 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

US (1)