Topical Bimatoprost in the Treatment of Migraine

Phase 2UnknownNCT03419715

Manistee Partners70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Migraine Disorders Headache Disorders

Interventions

Bimatoprost Topical SolutionDRUG

One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed

ControlDRUG

One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, United States

Omega Medical Research

Warwick, Rhode Island, United States

Outcomes

Primary Outcomes

Reduction in Headache Frequency

Change from baseline in the average number of headache days per month

Time frame: 12 weeks

Secondary Outcomes

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)

Time frame: 12 weeks

Duration of Headaches

Change from baseline in the average duration of headaches

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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