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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-AP | Experimental | 15 mg 4-aminopyridine twice daily |
|
| Atenolol | Experimental | 25 mg atenolol twice daily |
|
| Placebo | Placebo Comparator | Masked placebo twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-aminopyridine | Drug | an oral drug to be swallowed |
| |
| Atenolol |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dizziness Handicap Score | Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment | 14 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Drug |
an oral drug to be swallowed |
|
| Placebo | Other | a masked placebo to be swallowed |
|
| 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 |
| D009422 | Nervous System Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |