NCT03419715

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Manistee Partners · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bimatoprost Topical Solution	One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
DRUG	Control	One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.

Timeline

• Start date: 2018-01-05
• Primary completion: 2019-04-25
• Completion: 2019-06-30
• First posted: 2018-02-05
• Last updated: 2019-04-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study