Topical Bimatoprost in the Treatment of Migraine

NCT ID: NCT03419715

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-05
• Study Completion Date: 2019-06-30

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.

Conditions

Migraine Disorders; Headache Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bimatoprost Topical Solution

0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks

Group Type: EXPERIMENTAL

Bimatoprost Topical Solution

Intervention Type: DRUG

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

Control

Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DRUG

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

Interventions

Bimatoprost Topical Solution

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

Intervention Type: DRUG

Control

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

Intervention Type: DRUG

Other Intervention Names

Lumigan; placebo

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,
• Pregnancy and lactation, and
• Sexually active women of child bearing age who do not use any method of contraception.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manistee Partners

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L Bratzler, PhD

Role: STUDY_CHAIR

Manistee Partners

Locations

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, United States

Omega Medical Research

Warwick, Rhode Island, United States

Countries

United States

References

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.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

17-MAN-001

Identifier Type: -

Identifier Source: org_study_id