Status:
UNKNOWN
Topical Bimatoprost in the Treatment of Migraine
Lead Sponsor:
Manistee Partners
Conditions:
Migraine Disorders
Headache Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 qual...
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 du...
Eligibility Criteria
Inclusion
- Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.
Exclusion
- 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.
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03419715
Start Date
January 5 2018
End Date
June 30 2019
Last Update
April 26 2019
Active Locations (2)
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1
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, United States, 45212
2
Omega Medical Research
Warwick, Rhode Island, United States, 02886