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

Migraine Disorders Clinical Trial

Official title:

Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03578354
• Other study ID #: Pending
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2019
• Est. completion date: January 2024

Study information

• Verified date: January 2019
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Vestibular Diseases
• Vestibular Migraine

Intervention

Drug:
• 4-aminopyridine
an oral drug to be swallowed
• Atenolol
an oral drug to be swallowed

Other:
• Placebo
a masked placebo to be swallowed

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dizziness Handicap Score	Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment	14 weeks
Secondary	Change in number of dizziness episodes	Incidence of dizziness episodes will be compared pre- and post- study drug treatment	14 weeks
Secondary	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.	14 weeks
Secondary	Change in roll tilt perceptual threshold	Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment	14 weeks
Secondary	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	14 weeks
Secondary	Change in number of migraine episodes	Incidence of migraine episodes will be compared pre- and post- study drug treatment	14 weeks
Secondary	Change in Headache Impact Test (HIT) score	Headache Impact Test (HIT) will be compared pre- and post- study drug treatment	14 weeks
Secondary	Change in quality of life score	Quality of life will be measured using 36-Item Short Form Health Survey (SF-36) questionnaires and compared pre- and post- study drug treatment. The SF-36 consists of 8 sub-scores. Each score is reported as a scale (0 - 100) with 0 being maximally disabled and 100 having no disability.	14 weeks