Topical Bimatoprost in the Treatment of Migraine
Primary Purpose
Migraine Disorders, Headache Disorders
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost Topical Solution
Control
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Disorders focused on measuring migraine, headache, bimatoprost
Eligibility Criteria
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.
Sites / Locations
- CTI Clinical Trial and Consulting Services
- Omega Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bimatoprost Topical Solution
Control
Arm Description
0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks
Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
Outcomes
Primary Outcome Measures
Reduction in Headache Frequency
Change from baseline in the average number of headache days per month
Secondary Outcome Measures
Intensity of Headaches
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
Change from baseline in the average duration of headaches
Migraine Disability Assessment Scale (MIDAS)--Quality of Life
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03419715
Brief Title
Topical Bimatoprost in the Treatment of Migraine
Official Title
A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manistee Partners
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Headache Disorders
Keywords
migraine, headache, bimatoprost
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost Topical Solution
Arm Type
Experimental
Arm Description
0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Bimatoprost Topical Solution
Other Intervention Name(s)
Lumigan
Intervention Description
One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
placebo
Intervention Description
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
Primary Outcome Measure Information:
Title
Reduction in Headache Frequency
Description
Change from baseline in the average number of headache days per month
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intensity of Headaches
Description
Change from baseline in the average intensity of headaches on a scale of 0 (no pain at all) to 10 (life-threatening pain)
Time Frame
12 weeks
Title
Duration of Headaches
Description
Change from baseline in the average duration of headaches
Time Frame
12 weeks
Title
Migraine Disability Assessment Scale (MIDAS)--Quality of Life
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Bratzler, PhD
Organizational Affiliation
Manistee Partners
Official's Role
Study Chair
Facility Information:
Facility Name
CTI Clinical Trial and Consulting Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Learn more about this trial
Topical Bimatoprost in the Treatment of Migraine
We'll reach out to this number within 24 hrs