Topical Bimatoprost in the Treatment of Episodic Migraine
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|ClinicalTrials.gov Identifier: NCT03419715|
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders Headache Disorders||Drug: Bimatoprost Topical Solution Drug: Control||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Episodic Migraine|
|Actual Study Start Date :||January 5, 2018|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
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 Name: Lumigan
Placebo Comparator: Control
Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
Other Name: placebo
- Reduction in Headache Frequency [ Time Frame: 12 weeks ]Change from baseline in the average number of headache days per month
- Intensity of Headaches [ Time Frame: 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 [ Time Frame: 12 weeks ]Change from baseline in the average duration of headaches
- Quality of Life [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419715
|Contact: Dianna Gubber-Markley, RNfirstname.lastname@example.org|
|United States, Massachusetts|
|New England Regional Headache Center||Recruiting|
|Worcester, Massachusetts, United States, 01605|
|Contact: Dianna Gubber-Markley, RN 508-890-5633 email@example.com|
|Principal Investigator:||Herbert G Markley, MD||New England Regional Headache Center|