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Timolol Eye Drops in the Treatment of Acute Migraine Headache

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ClinicalTrials.gov Identifier: NCT02630719
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Migraine Drug: Timolol eye drops Drug: Artificial tears

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Timolol Eye Drops in the Treatment of Acute Migraine Headache
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: timolol eye drops
Treatment with timolol eye drops at the onset of an acute migraine headache
Drug: Timolol eye drops
eye drops
Placebo Comparator: Placebo eye drop
Treatment with artificial eye drops at the onset of an acute migraine headache
Drug: Artificial tears
Placebo drop


Outcome Measures

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

    Subjects will maintain a headache diary that records time of headache onset or recurrence. Each headache occurrence will be given a headache intensity rating based on a four point scale recommended by the International Headache Society (0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache).

    Also recorded for each headache will be the extent of functional impairment on a four point scale (0=function and work normally, 1=mild impairment, 2=severe impairment, 3=requiring bed rest).

    Any associated symptoms (eg, nausea, vomiting, photophobia, phonophobia), headache recurrences, uses of rescue medications, and adverse events will be recorded in the headache diary.

    At followup visits (1 month, 3 month, 6 month and 1 year), subjects will rate the overall effectiveness of the medication on a four point scale (0=poor, 1=fair, 2=good, 3=execellent).



Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Matthew Cossack, MD 816-404-1780 matthew.cossack@tmcmed.org
Contact: Sean Gratton, MD 816-404-1000 Sean.Gratton@tmcmed.org

Locations
United States, Missouri
Truman Medical Center Recruiting
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Missouri, Kansas City
Truman Medical Center
Investigators
Principal Investigator: Sean Gratton, MD UMKC
More Information

Responsible Party: Sean Gratton, Assistant Professor and Staff Physician, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT02630719     History of Changes
Other Study ID Numbers: 15-152
#15-060 ( Other Identifier: Truman Medical Center )
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Sean Gratton, University of Missouri, Kansas City:
headache

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ophthalmic Solutions
Tetrahydrozoline
Timolol
Lubricant Eye Drops
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents