Topical Bimatoprost in the Treatment of Migraine

Phase 2

• Conditions: Migraine Disorders; Headache Disorders
• Interventions: Drug: Control; Drug: Bimatoprost Topical Solution

• Registration Number: NCT03419715
• Lead Sponsor: Manistee Partners

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.

Study Timeline

• Study Start: 2018-01-05
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Status Verified: 2019-04
• Primary Completion: 2019-04-25
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
Bimatoprost Topical Solution	Bimatoprost Topical Solution	0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks

Primary Outcome Measures

Name	Time	Method
Reduction in Headache Frequency	12 weeks	Change from baseline in the average number of headache days per month

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

CTI Clinical Trial and Consulting Services; 🇺🇸 Cincinnati, Ohio, United States