MigraineNCT02630719
Timolol Eye Drops in the Treatment of Acute Migraine Headache
A study testing Timolol eye drops and Artificial tears in people with Migraine, run by University of Missouri, Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Timolol eye drops and Artificial tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of migraine headache
Who cannot join
- 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
Show all 10Show fewer
- Inability to self-administer eye drop due to physical or cognitive disorders
- Currently pregnant or breastfeeding
- Pregnant in the past year
- Non-english speaker
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Migraine
- Being tested
- Timolol eye drops, Artificial tears
- Keywords
- headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol eye dropsDrug
eye drops
Artificial tearsDrug
Placebo drop
| Study group | Role | What they receive |
|---|---|---|
| Timolol eye drops | Active comparator | 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. Receives: Drug: Timolol eye drops |
| Artificial tears | Placebo comparator | 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. Receives: Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Why it stopped: Unable to enroll sufficient participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Truman Medical Center
- Responsible party
- Principal investigator, Sean Gratton, University of Missouri, Kansas City
- Investigators
- Sean Gratton, MD, Principal investigator, UMKC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630719
- Sponsor's protocol ID
- 15-152
- Other IDs
- #15-060
- Status last verified
- Apr 2019
- First submitted
- 25 Nov 2015
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29799915
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timolol Eye Drops in the Treatment of Acute Migraine Headache
- ClinicalTrials.gov ID
- NCT02630719
- Acronym / sponsor ID
- 15-152
- Conditions
- Migraine
- Keywords
- headache
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll sufficient participants
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- Truman Medical Center
- Study start
- Jan 2016
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol eye drops | Active comparator | Drug: Timolol eye dropsAll 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 | Placebo comparator | Drug: Artificial tearsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of migraine headache
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timolol eye dropseye drops | Drug | Timolol eye drops |
| Artificial tearsPlacebo drop | Drug | Artificial tears |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29799915Cossack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Gratton, MD principal investigator
UMKC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timolol eye drops and Artificial tears in people with Migraine, run by University of Missouri, Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timolol Eye Drops in the Treatment of Acute Migraine Headache (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.