Topical Bimatoprost in the Treatment of Migraine

Migraine Disorders Clinical Trial

Official title:

A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03419715
• Other study ID #: 17-MAN-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 5, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2019
• Source: Manistee Partners
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 30, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Headache
• Headache Disorders
• Migraine Disorders

Intervention

Drug:
• Bimatoprost Topical Solution
One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
• Control
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.

Locations

Country	Name	City	State
United States	CTI Clinical Trial and Consulting Services	Cincinnati	Ohio
United States	Omega Medical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Manistee Partners

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Headache Frequency	Change from baseline in the average number of headache days per month	12 weeks
Secondary	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
Secondary	Duration of Headaches	Change from baseline in the average duration of headaches	12 weeks
Secondary	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