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Corticosteroid
BHV-2100 for Migraine
Phase 2
Recruiting
Research Sponsored by Biohaven Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
2-8 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Period
Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
Must not have
Participants with a history of basilar migraine or hemiplegic migraine
Participants who have taken medication for acute treatment of headache (including triptans, ergotamine, opioids, acetaminophen, NSAIDs, or combination analgesics) on 10 or more days in any of the 3 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 2 hours up to 48 hours post-dose
Summary
"This trial aims to find a safe and effective dose of BHV-2100 to reduce headache pain and other symptoms in people with migraines."
Who is the study for?
This trial is for individuals who experience migraine headaches. Specific details about eligibility criteria are not provided, but typically participants must have a history of migraines and meet certain health conditions to be included.
What is being tested?
The study aims to determine the safety and effectiveness of at least one dose of BHV-2100 in alleviating headache pain and other symptoms associated with migraines, compared to a placebo (a substance with no active drug).
What are the potential side effects?
While specific side effects are not listed here, common side effects for migraine medications can include nausea, dizziness, fatigue, dry mouth, and sensitivity to touch or pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had 2-8 moderate or severe migraines monthly for the last 3 months.
Select...
I have been diagnosed with migraines for at least 1 year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of basilar or hemiplegic migraine.
Select...
I have taken headache medication on 10+ days in a month recently.
Select...
I have had surgery on my stomach or small intestine, or have a condition that affects how my body absorbs nutrients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 2 hours up to 48 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 2 hours up to 48 hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
Secondary study objectives
Number of Participants with Deaths, Serious AEs (SAEs), and moderate or severe AEs
Number of Subjects with Clinically Significant Laboratory Abnormalities
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
+10 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV-2100 75 mgExperimental Treatment1 Intervention
Group II: BHV-2100 150 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Biohaven Therapeutics Ltd.Lead Sponsor
11 Previous Clinical Trials
4,121 Total Patients Enrolled