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

Phase 2

Withdrawn

• Conditions: Migraine Disorders; Vestibular Diseases; Vestibular Migraine
• Interventions: Drug: Atenolol; Other: Placebo; Drug: 4-aminopyridine

• Registration Number: NCT03578354
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-06
• Study Start: 2019-01
• Primary Completion: 2023-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atenolol	Atenolol	25 mg atenolol twice daily
Placebo	Placebo	Masked placebo twice daily
4-AP	4-aminopyridine	15 mg 4-aminopyridine twice daily

Primary Outcome Measures

Name	Time	Method
Change in Dizziness Handicap Score	14 weeks	Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment

Secondary Outcome Measures

Name	Time	Method
Change in number of dizziness episodes	14 weeks	Incidence of dizziness episodes will be compared pre- and post- study drug treatment
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 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

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States