Topical Bimatoprost in the Treatment of Migraine

Manistee Partners

Status and phase: Unknown; Phase 2

Conditions: Headache Disorders; Migraine Disorders

Treatments: Drug: Control; Drug: Bimatoprost Topical Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03419715

17-MAN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Bimatoprost Topical Solution

Experimental group

Description:

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

Treatment:

Drug: Bimatoprost Topical Solution

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Control