Migraine Disorders, Vestibular Diseases, Vestibular Migraine
Conditions
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.
Interventions
DRUG4-aminopyridine
an oral drug to be swallowed
DRUGAtenolol
an oral drug to be swallowed
OTHERPlacebo
a masked placebo to be swallowed
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dizziness Handicap Score | 14 weeks | Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in motion sickness susceptibility | 14 weeks | 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. |
| Change in roll tilt perceptual threshold | 14 weeks | Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment |
| Change in vestibulo-ocular reflex (VOR) time constant | 14 weeks | Standard low-frequency rotational testing to measure VOR will be compared pre- and post- study drug treatment |
| Change in number of dizziness episodes | 14 weeks | Incidence of dizziness episodes will be compared pre- and post- study drug treatment |
| Change in Headache Impact Test (HIT) score | 14 weeks | Headache Impact Test (HIT) will be compared pre- and post- study drug treatment |
| Change in quality of life score | 14 weeks | 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. |
| Change in number of migraine episodes | 14 weeks | Incidence of migraine episodes will be compared pre- and post- study drug treatment |
Countries
United States
Outcome results
None listed