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Trial record 17 of 116 for:    Atenolol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578354
Recruitment Status : Withdrawn (Funding not acquired)
First Posted : July 6, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Lewis, Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE May 31, 2018
First Posted Date  ICMJE July 6, 2018
Last Update Posted Date January 8, 2019
Estimated Study Start Date  ICMJE January 2019
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
Change in Dizziness Handicap Score [ Time Frame: 14 weeks ]
Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03578354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • Change in number of dizziness episodes [ Time Frame: 14 weeks ]
    Incidence of dizziness episodes will be compared pre- and post- study drug treatment
  • 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.
  • Change in roll tilt perceptual threshold [ Time Frame: 14 weeks ]
    Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment
  • 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
  • Change in number of migraine episodes [ Time Frame: 14 weeks ]
    Incidence of migraine episodes will be compared pre- and post- study drug treatment
  • Change in Headache Impact Test (HIT) score [ Time Frame: 14 weeks ]
    Headache Impact Test (HIT) will be compared pre- and post- study drug treatment
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine
Official Title  ICMJE Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Migraine
  • Migraine Disorders
  • Vestibular Diseases
Intervention  ICMJE
  • Drug: 4-aminopyridine
    an oral drug to be swallowed
  • Drug: Atenolol
    an oral drug to be swallowed
  • Other: Placebo
    a masked placebo to be swallowed
Study Arms  ICMJE
  • Experimental: 4-AP
    15 mg 4-aminopyridine twice daily
    Intervention: Drug: 4-aminopyridine
  • Experimental: Atenolol
    25 mg atenolol twice daily
    Intervention: Drug: Atenolol
  • Placebo Comparator: Placebo
    Masked placebo twice daily
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 4, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2018)
219
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03578354
Other Study ID Numbers  ICMJE Pending
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Lewis, Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP