Back to results4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine
Primary Purpose
Vestibular Migraine, Migraine Disorders, Vestibular Diseases
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
4-aminopyridine
Atenolol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Migraine
Eligibility Criteria
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
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
4-AP
Atenolol
Placebo
Arm Description
15 mg 4-aminopyridine twice daily
25 mg atenolol twice daily
Masked placebo twice daily
Outcomes
Primary Outcome Measures
Change in Dizziness Handicap Score
Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment
Secondary Outcome Measures
Change in number of dizziness episodes
Incidence of dizziness episodes will be compared pre- and post- study drug treatment
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.
Change in roll tilt perceptual threshold
Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment
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
Change in number of migraine episodes
Incidence of migraine episodes will be compared pre- and post- study drug treatment
Change in Headache Impact Test (HIT) score
Headache Impact Test (HIT) will be compared pre- and post- study drug treatment
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.
Full Information
NCT ID
NCT03578354
First Posted
May 31, 2018
Last Updated
January 4, 2019
Sponsor
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT03578354
Brief Title
4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine
Official Title
Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not acquired
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Migraine, Migraine Disorders, Vestibular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4-AP
Arm Type
Experimental
Arm Description
15 mg 4-aminopyridine twice daily
Arm Title
Atenolol
Arm Type
Experimental
Arm Description
25 mg atenolol twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Masked placebo twice daily
Intervention Type
Drug
Intervention Name(s)
4-aminopyridine
Intervention Description
an oral drug to be swallowed
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Description
an oral drug to be swallowed
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
a masked placebo to be swallowed
Primary Outcome Measure Information:
Title
Change in Dizziness Handicap Score
Description
Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Change in number of dizziness episodes
Description
Incidence of dizziness episodes will be compared pre- and post- study drug treatment
Time Frame
14 weeks
Title
Change in motion sickness susceptibility
Description
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
Title
Change in roll tilt perceptual threshold
Description
Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment
Time Frame
14 weeks
Title
Change in vestibulo-ocular reflex (VOR) time constant
Description
Standard low-frequency rotational testing to measure VOR will be compared pre- and post- study drug treatment
Time Frame
14 weeks
Title
Change in number of migraine episodes
Description
Incidence of migraine episodes will be compared pre- and post- study drug treatment
Time Frame
14 weeks
Title
Change in Headache Impact Test (HIT) score
Description
Headache Impact Test (HIT) will be compared pre- and post- study drug treatment
Time Frame
14 weeks
Title
Change in quality of life score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine
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