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

Study Overview
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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.

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

Conditions
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Vestibular Migraine, Migraine Disorders, Vestibular Diseases

Intervention / Treatment
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* Drug: 4-aminopyridine
* Drug: Atenolol
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-AP<br>15 mg 4-aminopyridine twice daily | Drug: 4-aminopyridine<br>* an oral drug to be swallowed<br>|
| Experimental: Atenolol<br>25 mg atenolol twice daily | Drug: Atenolol<br>* an oral drug to be swallowed<br>|
| Placebo Comparator: Placebo<br>Masked placebo twice daily | Other: Placebo<br>* a masked placebo to be swallowed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dizziness Handicap Score | Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of dizziness episodes | Incidence of dizziness episodes will be compared pre- and post- study drug treatment | 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. | 14 weeks | 
| Change in roll tilt perceptual threshold | Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment | 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 | 14 weeks | 
| Change in number of migraine episodes | Incidence of migraine episodes will be compared pre- and post- study drug treatment | 14 weeks | 
| Change in Headache Impact Test (HIT) score | Headache Impact Test (HIT) will be compared pre- and post- study drug treatment | 14 weeks | 
| 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 |