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| ID | Type | Description | Link |
|---|---|---|---|
| #15-060 | Other Identifier | Truman Medical Center |
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Unable to enroll sufficient participants
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| Name | Class |
|---|---|
| Truman Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol eye drops | Drug | eye drops |
| |
| Artificial tears |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 4 months |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sean Gratton, MD | UMKC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29799915 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Timolol Eye Drops First | Timolol ophthalmic solution 0.5% first, then Artificial Tears 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. Each intervention period is 2 months with a 4 day washout period in between. |
| FG001 | Artificial Tears First | Artificial tears first, then timolol ophthalmic solution 0.5% 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. Each intervention period is 2 months with a 4 day washout period in between. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| Posted | Mean | Standard Deviation | percentage of migraine attacks at 0 or 1 | 4 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Timolol Eye Drops | Treatment with timolol eye drops at the onset of an acute migraine headache Timolol eye drops: eye drops |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Gratton MD | Truman Medical Center | 816-404-5275 | sean.gratton@tmemed.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 4, 2016 | Sep 17, 2018 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 18, 2015 | Apr 22, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2019 | Apr 22, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
Placebo drop |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Artificial Tears | Treatment with artificial eye drops at the onset of an acute migraine headache Artificial tears: Placebo drop | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |