Timolol Eye Drops in the Treatment of Acute Migraine Headache

NCT ID: NCT02630719

Last Updated: 2019-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Timolol eye drops

Intervention Type DRUG

eye drops

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.

Group Type PLACEBO_COMPARATOR

Artificial tears

Intervention Type DRUG

Placebo drop

Interventions

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Timolol eye drops

eye drops

Intervention Type DRUG

Artificial tears

Placebo drop

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Truman Medical Center

OTHER

Sponsor Role collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Sean Gratton

Assistant Professor and Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Gratton, MD

Role: PRINCIPAL_INVESTIGATOR

UMKC

Locations

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Truman Medical Center

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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Cossack M, Nabrinsky E, Turner H, Abraham A, Gratton S. Timolol Eyedrops in the Treatment of Acute Migraine Attacks: A Randomized Crossover Study. JAMA Neurol. 2018 Aug 1;75(8):1024-1025. doi: 10.1001/jamaneurol.2018.0970.

Reference Type DERIVED
PMID: 29799915 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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#15-060

Identifier Type: OTHER

Identifier Source: secondary_id

15-152

Identifier Type: -

Identifier Source: org_study_id

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