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

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ClinicalTrials.gov Identifier: NCT03578354
Recruitment Status : Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Lewis, 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.

Condition or disease Intervention/treatment Phase
Vestibular Migraine Migraine Disorders Vestibular Diseases Drug: 4-aminopyridine Drug: Atenolol Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4-AP
15 mg 4-aminopyridine twice daily
Drug: 4-aminopyridine
an oral drug to be swallowed

Experimental: Atenolol
25 mg atenolol twice daily
Drug: Atenolol
an oral drug to be swallowed

Placebo Comparator: Placebo
Masked placebo twice daily
Other: Placebo
a masked placebo to be swallowed




Primary Outcome Measures :
  1. Change in Dizziness Handicap Score [ Time Frame: 14 weeks ]
    Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment


Secondary Outcome Measures :
  1. Change in number of dizziness episodes [ Time Frame: 14 weeks ]
    Incidence of dizziness episodes will be compared pre- and post- study drug treatment

  2. Change in motion sickness susceptibility [ Time Frame: 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.

  3. Change in roll tilt perceptual threshold [ Time Frame: 14 weeks ]
    Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment

  4. Change in vestibulo-ocular reflex (VOR) time constant [ Time Frame: 14 weeks ]
    Standard low-frequency rotational testing to measure VOR will be compared pre- and post- study drug treatment

  5. Change in number of migraine episodes [ Time Frame: 14 weeks ]
    Incidence of migraine episodes will be compared pre- and post- study drug treatment

  6. Change in Headache Impact Test (HIT) score [ Time Frame: 14 weeks ]
    Headache Impact Test (HIT) will be compared pre- and post- study drug treatment

  7. Change in quality of life score [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578354


Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Amy Quinkert, PhD    617-573-4192    amy_quinkert@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary

Responsible Party: Richard Lewis, Associate Professor, Otolaryngology and Neurology; Director, Jenks Vestibular Laboratory, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03578354     History of Changes
Other Study ID Numbers: Pending
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Migraine Disorders
Vestibular Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Atenolol
4-Aminopyridine
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Potassium Channel Blockers
Membrane Transport Modulators