Topical Bimatoprost in the Treatment of Migraine
A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
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.
One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks
Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
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.