Timolol Eye Drops in the Treatment of Acute Migraine Headache
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Timolol Eye Drops in the Treatment of Acute Migraine Headache
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Timolol eye drops (Drug)
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.
Intervention: Artificial tears (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Sean Gratton
Assistant Professor and Staff Physician
University of Missouri, Kansas City