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Timolol Eye Drops in the Treatment of Acute Migraine Headache

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: NCT02630719
Recruitment Status : Terminated (Unable to enroll sufficient participants)
First Posted : December 15, 2015
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Truman Medical Center
Information provided by (Responsible Party):
Sean Gratton, University of Missouri, Kansas City

Brief Summary:
The goal of this study is to determine whether timolol eye drops are effective in alleviating acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or placebo (tears) to use as a migraine abortive medication.

Condition or disease Intervention/treatment Phase
Migraine Drug: Timolol eye drops Drug: Artificial tears Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Timolol Eye Drops in the Treatment of Acute Migraine Headache
Study Start Date : January 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arm Intervention/treatment
Active Comparator: Timolol eye drops
All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study.
Drug: Timolol eye drops
eye drops

Placebo Comparator: Artificial tears
All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study.
Drug: Artificial tears
Placebo drop




Primary Outcome Measures :
  1. Timolol Eye Drops in the Treatment of Acute Migraine Headache [ Time Frame: 4 months ]

    Percent of migraine attacks at 0 or 1 on the 4-point Rating Scale recommended by the International Headache Society:

    0: no headache

    1. mild headache
    2. moderate headaches
    3. severe headache



Information from the National Library of Medicine

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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:

  • Diagnosis of migraine headache

Exclusion Criteria

  • Non-migraine headache
  • Use of systemic beta-blocker
  • Medical history of hypotension, bradycardia, syncope or other significant cardiovascular disease
  • Medical history of difficulty breathing, asthma or chronic obstructive pulmonary disease or other pulmonary disease
  • Medical history of glaucoma, ocular hypertension or hypotony, punctual stenosis, current use of other ophthalmic medications
  • Previous adverse reaction to timolol or other beta-blockers
  • Inability to self-administer eye drop due to physical or cognitive disorders
  • Currently pregnant or breastfeeding
  • Pregnant in the past year
  • Non-english speaker

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): NCT02630719


Locations
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United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Missouri, Kansas City
Truman Medical Center
Investigators
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Principal Investigator: Sean Gratton, MD UMKC
  Study Documents (Full-Text)

Documents provided by Sean Gratton, University of Missouri, Kansas City:
Informed Consent Form  [PDF] August 4, 2016
Study Protocol  [PDF] March 18, 2015
Statistical Analysis Plan  [PDF] April 22, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sean Gratton, Assistant Professor and Staff Physician, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT02630719    
Other Study ID Numbers: 15-152
#15-060 ( Other Identifier: Truman Medical Center )
First Posted: December 15, 2015    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019
Keywords provided by Sean Gratton, University of Missouri, Kansas City:
headache
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Timolol
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents