Topical Bimatoprost in the Treatment of Migraine



Status:Recruiting
Conditions:Migraine Headaches, Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:9/21/2018
Start Date:January 5, 2018
End Date:December 2018
Contact:Robert L Bratzler, PhD
Email:rbratzler@gmail.com
Phone:6175387105

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

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.

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.
We found this trial at
2
sites
100 East Rivercenter Boulevard
Cincinnati, Ohio 45242
Principal Investigator: James Maynard, MD
Phone: 513-841-5300
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Cincinnati, OH
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
Principal Investigator: David L Fried, MD
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Warwick, RI
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