A Phase 2 interventional study of 4-aminopyridine and Atenolol in Vestibular Migraine, Migraine Disorders and Vestibular Diseases, sponsored by Massachusetts Eye and Ear Infirmary. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Massachusetts Eye and Ear Infirmary · Phase 2, Interventional, and Treatment
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.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
Browse Migraine Disorders studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
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Exclusion Criteria:
15 mg 4-aminopyridine twice daily
Drug: 4-aminopyridine
25 mg atenolol twice daily
Drug: Atenolol
Masked placebo twice daily
Other: Placebo
an oral drug to be swallowed
an oral drug to be swallowed
a masked placebo to be swallowed
Change in Dizziness Handicap Score
Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment
Time frame: 14 weeks
Change in number of dizziness episodes
Incidence of dizziness episodes will be compared pre- and post- study drug treatment
Time frame: 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.
Time frame: 14 weeks
Change in roll tilt perceptual threshold
Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment
Time frame: 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
Time frame: 14 weeks
Change in number of migraine episodes
Incidence of migraine episodes will be compared pre- and post- study drug treatment
Time frame: 14 weeks
Change in Headache Impact Test (HIT) score
Headache Impact Test (HIT) will be compared pre- and post- study drug treatment
Time frame: 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.
Time frame: 14 weeks
This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: 4-Aminopyridine · Atenolol
Massachusetts Eye and Ear Infirmary →