Timolol Eye Drops in the Treatment of Acute Migraine Headache

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02630719

Enrollment

Registered

2015-12-15

Start date

2016-01-31

Completion date

2017-08-01

Last updated

2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

headache

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.

Interventions

DRUGTimolol eye drops

eye drops

DRUGArtificial tears

Placebo drop

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Timolol Eye Drops First Treatment with timolol eye drops at the onset of an acute migraine headache for the first 2 months, then a 4 day washout period, followed by Artificial tears at the onset of an acute migraine headache for the next 2 months. Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.	4
Artifical Tears First Treatment with artificial eye drops at the onset of an acute migraine headache for the first 2 months, then a 4 day washout period, followed by timolol eye drops at the onset of an acute migraine headache for the next 2 months. Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.	6
Total	10

Baseline characteristics

Characteristic	Timolol Eye Drops First	Artifical Tears First	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	1 Participants
Age, Categorical Between 18 and 65 years	4 Participants	5 Participants	9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	3 Participants	6 Participants	9 Participants
Region of Enrollment United States	4 Participants	6 Participants	10 Participants
Sex: Female, Male Female	4 Participants	4 Participants	8 Participants
Sex: Female, Male Male	0 Participants	2 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 10
other Total, other adverse events	0 / 10	0 / 10
serious Total, serious adverse events	0 / 10	0 / 10

Outcome results

Primary