Headache Disorders, Migraine Disorders
Conditions
Keywords
migraine, headache, bimatoprost
Brief summary
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
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.
Interventions
DRUGBimatoprost Topical Solution
One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
DRUGControl
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
Sponsors
Manistee Partners
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Headache Frequency | 12 weeks | Change from baseline in the average number of headache days per month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Headaches | 12 weeks | Change from baseline in the average intensity of headaches on a scale of 0 (no pain at all) to 10 (life-threatening pain) |
| Duration of Headaches | 12 weeks | Change from baseline in the average duration of headaches |
| Migraine Disability Assessment Scale (MIDAS)--Quality of Life | 12 weeks | 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. |
Countries
United States
Outcome results
None listed