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The study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. It will also assess the effect of topical bimatoprost on quality of life.
Hall, et al. have observed retrospectively that treatment with topical prostaglandin F2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (MIDAS).
This is a double-blind, placebo-controlled prospective clinical study to determine if the effect of FDA-approved bimatoprost, a prostaglandin F2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost Topical Solution | Experimental | 0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks |
|
| Control | Placebo Comparator | Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost Topical Solution | Drug | One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Headache Frequency | Change from baseline in the average number of headache days per month | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Headaches | Change from baseline in the average intensity of headaches on a scale of 0 (no pain at all) to 10 (life-threatening pain) | 12 weeks |
| Duration of Headaches | Change from baseline in the average duration of headaches |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Bratzler, PhD | Manistee Partners | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTI Clinical Trial and Consulting Services | Cincinnati | Ohio | 45212 | United States | ||
| Omega Medical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Hall LB et al. The Effect of Topical Prostaglandins on Migraine Headaches. Poster Presentation at the Association for Research in Vision and Ophthalmology Annual Meeting, May 2017. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2018 | Jan 23, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020773 | Headache Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
| Control | Drug | One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand. |
|
|
| 12 weeks |
| Migraine Disability Assessment Scale (MIDAS)--Quality of Life | Change from baseline in quality of life as measured by the Migraine Disability Assessment Scale (MIDAS). MIDAS is a five-item instrument developed to measure migraine related disability and functional consequences. It is divided into four categories based on the score of: 0-5, minimal disability; 6-10, mild disability; 11-20, moderate disability; greater than 20; severe disability. | 12 weeks |
| Warwick |
| Rhode Island |
| 02886 |
| United States |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |