Topical Bimatoprost in the Treatment of Migraine

Sponsor

Manistee Partners (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03419715

Collaborator

(none)

Enrollment

Locations

Arms

17.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders Headache Disorders	Drug: Bimatoprost Topical Solution Drug: Control	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 5, 2018

Actual Primary Completion Date :

Apr 25, 2019

Anticipated Study Completion Date :

Jun 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction in Headache Frequency [12 weeks]
Change from baseline in the average number of headache days per month

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.