Timolol Eye Drops in the Treatment of Acute Migraine Headache

Not Applicable

Terminated

• Conditions: Migraine
• Interventions: Drug: Timolol eye drops; Drug: Artificial tears

• Registration Number: NCT02630719
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Study Start: 2016-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Results First Submitted: 2018-11-18
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Results First Posted: 2019-05-15
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Timolol eye drops	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.
Artificial tears	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.

Primary Outcome Measures

Name	Time	Method
Timolol Eye Drops in the Treatment of Acute Migraine Headache	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

Trial Locations

Locations (1)

Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States