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.

Study Overview

• Status: Unknown
• Conditions: Migraine Disorders; Headache Disorders
• Intervention / Treatment: Drug: Bimatoprost Topical Solution; Drug: Control

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Trial and Consulting Services
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimatoprost Topical Solution; 0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks	Drug: Bimatoprost Topical Solution; One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed; Other Names: Lumigan
Placebo Comparator: Control; Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks	Drug: Control; One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Headache Frequency	Change from baseline in the average number of headache days per month	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks
Duration of Headaches	Change from baseline in the average duration of headaches	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.	12 weeks

Collaborators and Investigators

• Sponsor: Manistee Partners
• Investigators: Study Chair: Robert L Bratzler, PhD, Manistee Partners

Publications and helpful links

General Publications

• Hall LB et al. The Effect of Topical Prostaglandins on Migraine Headaches. Poster Presentation at the Association for Research in Vision and Ophthalmology Annual Meeting, May 2017.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): April 25, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: headache; migraine; bimatoprost
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Disease; Migraine Disorders; Headache; Headache Disorders; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 17-MAN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes