Back to resultsTimolol Eye Drops in the Treatment of Acute Migraine Headache
Primary Purpose
Migraine
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Timolol eye drops
Artificial tears
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring headache
Eligibility 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
Sites / Locations
- Truman Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Timolol eye drops
Artificial tears
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Percent of migraine attacks at 0 or 1 on the 4-point Rating Scale recommended by the International Headache Society:
0: no headache
mild headache
moderate headaches
severe headache
Secondary Outcome Measures
Full Information
NCT ID
NCT02630719
First Posted
November 25, 2015
Last Updated
April 22, 2019
Sponsor
University of Missouri, Kansas City
Collaborators
Truman Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02630719
Brief Title
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Official Title
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll sufficient participants
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City
Collaborators
Truman Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Timolol eye drops
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Artificial tears
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Timolol eye drops
Intervention Description
eye drops
Intervention Type
Drug
Intervention Name(s)
Artificial tears
Intervention Description
Placebo drop
Primary Outcome Measure Information:
Title
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Description
Percent of migraine attacks at 0 or 1 on the 4-point Rating Scale recommended by the International Headache Society:
0: no headache
mild headache
moderate headaches
severe headache
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Gratton, MD
Organizational Affiliation
UMKC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29799915
Citation
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. Erratum In: JAMA Neurol. 2018 Aug 1;75(8):1028. JAMA Neurol. 2018 Oct 1;75(10):1287.
Results Reference
derived
Learn more about this trial
Timolol Eye Drops in the Treatment of Acute Migraine Headache
We'll reach out to this number within 24 hrs