Topical Bimatoprost in the Treatment of Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine

Conditions
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Headache Disorders, Migraine Disorders

Intervention / Treatment
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* Drug: Bimatoprost Topical Solution
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month. Exclusion Criteria: Significant liver or renal dysfunction, On treatment for inflammatory bowel disease, medication over-use for headaches according to the ICHD II criteria, Use of antipsychotics in the past month, Recent (in the past six months) history of alcohol or drug abuse, Allergy to bimatoprost and its compounds, Severe comorbid psychiatric illness, Severe infection, Malignancy, Severe cardiovascular disease, Neurodegenerative disorders, Pregnancy and lactation, and Sexually active women of child bearing age who do not use any method of contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost Topical Solution<br>0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks | Drug: Bimatoprost Topical Solution<br>* One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed<br>* Other names: Lumigan;|
| Placebo Comparator: Control<br>Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks | Drug: Control<br>* One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Headache Frequency | Change from baseline in the average number of headache days per month | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache, bimatoprost