Topical Bimatoprost in the Treatment of Migraine
A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
1 other identifier
interventional
70
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2018
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2018
CompletedFirst Submitted
Initial submission to the registry
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedApril 26, 2019
April 1, 2019
1.3 years
January 23, 2018
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Headache Frequency
Change from baseline in the average number of headache days per month
12 weeks
Secondary Outcomes (3)
Intensity of Headaches
12 weeks
Duration of Headaches
12 weeks
Migraine Disability Assessment Scale (MIDAS)--Quality of Life
12 weeks
Study Arms (2)
Bimatoprost Topical Solution
EXPERIMENTAL0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks
Control
PLACEBO COMPARATORSaline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
Interventions
One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
Eligibility Criteria
You may qualify if:
- Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert L Bratzler, PhD
Manistee Partners
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2018
First Posted
February 5, 2018
Study Start
January 5, 2018
Primary Completion
April 25, 2019
Study Completion
June 30, 2019
Last Updated
April 26, 2019
Record last verified: 2019-04