A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
Overview
- Phase
- Phase 2
- Intervention
- Bimatoprost Topical Solution
- Conditions
- Migraine Disorders
- Sponsor
- Manistee Partners
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Reduction in Headache Frequency
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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,
Arms & Interventions
Bimatoprost Topical Solution
0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks
Intervention: Bimatoprost Topical Solution
Control
Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
Intervention: Control
Outcomes
Primary Outcomes
Reduction in Headache Frequency
Time Frame: 12 weeks
Change from baseline in the average number of headache days per month
Secondary Outcomes
- Intensity of Headaches(12 weeks)
- Duration of Headaches(12 weeks)
- Migraine Disability Assessment Scale (MIDAS)--Quality of Life(12 weeks)