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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
Sponsor:
Information provided by (Responsible Party):
Manistee Partners

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Headache Disorders Drug: Bimatoprost Topical Solution Drug: Control Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
Drug Information available for: Bimatoprost
U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Control
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
Other Name: placebo



Primary Outcome Measures :
  1. Reduction in Headache Frequency [ Time Frame: 12 weeks ]
    Change from baseline in the average number of headache days per month


Secondary Outcome Measures :
  1. 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)

  2. Duration of Headaches [ Time Frame: 12 weeks ]
    Change from baseline in the average duration of headaches

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of episodic migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4-14 days per month, the internationally accepted definition of "episodic migraine" patients.

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.

Information from the National Library of Medicine

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


Contacts
Contact: Dianna Gubber-Markley, RN 5088905633 gubberdm@nerhc.org

Locations
United States, Massachusetts
New England Regional Headache Center Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Dianna Gubber-Markley, RN    508-890-5633    gubberdm@nerhc.org   
Sponsors and Collaborators
Manistee Partners
Investigators
Principal Investigator: Herbert G Markley, MD New England Regional Headache Center
  Study Documents (Full-Text)

Documents provided by Manistee Partners:
Study Protocol  [PDF] January 2, 2018


Publications of Results:
Hall LB et al. The Effect of Topical Prostaglandins on Migraine Headaches. Poster Presentation at the Association for Research in Vision and Ophthalmology Annual Meeting, May 2017.

Responsible Party: Manistee Partners
ClinicalTrials.gov Identifier: NCT03419715     History of Changes
Other Study ID Numbers: 17-MAN-001
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Manistee Partners:
migraine
headache
bimatoprost

Additional relevant MeSH terms:
Migraine Disorders
Disease
Headache
Headache Disorders
Pathologic Processes
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Bimatoprost
Antihypertensive Agents