Trial | NCT03419715  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    70
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.
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 Started
Jan 05
2018
Primary Completion
Apr 25
2019
Study Completion
Jun 30
2019
Anticipated
Last Update
Apr 26
2019

Drug Bimatoprost Topical Solution

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

  • Other names: Lumigan

Drug Control

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

  • Other names: placebo

Bimatoprost Topical Solution Experimental

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

Control Placebo Comparator

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

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.
No Results Posted