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Prostaglandin Analog
Bimatoprost Topical Solution for Migraine
Phase 2
Waitlist Available
Research Sponsored by Manistee Partners
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
This trial is testing if a skin-applied medication called bimatoprost can help people who suffer from migraines by reducing their headache symptoms and improving their quality of life.
Eligible Conditions
- Migraine
- Chronic Headaches
- Headache Disorders
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction in Headache Frequency
Secondary study objectives
Duration of Headaches
Intensity of Headaches
Migraine Disability Assessment Scale (MIDAS)--Quality of Life
Side effects data
From 2016 Phase 4 trial • 379 Patients • NCT020173271%
myocardial infarction
1%
hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumigan 0.01%
Monoprost
Lumigan 0.03% Unit Dose
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bimatoprost Topical SolutionExperimental Treatment1 Intervention
0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks
Group II: ControlPlacebo Group1 Intervention
Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
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Who is running the clinical trial?
Manistee PartnersLead Sponsor
Robert L Bratzler, PhDStudy ChairManistee Partners
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