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Elismetrep for Migraine
Birmingham, AL
Phase 2
Recruiting
Research Sponsored by Kallyope Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent
Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening (Visit 1)
Must not have
Is a female who is pregnant, breast-feeding or intends to become pregnant during the planned course of the study
Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the three months prior to screening (Visit 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 2 to 48 hours
Summary
This trial is testing a new drug called elismetrep to see if it is safe and effective in treating moderate or severe migraines. Participants will be randomly assigned to either receive the new drug or a
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Who is the study for?
Adults aged 18-70 with a history of migraines, experiencing 2-10 moderate to severe attacks per month. Participants must meet specific migraine criteria and have attack durations typical for migraines. Women must be postmenopausal or surgically sterile, while all participants agree to abstain from heterosexual activity or use contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Elismetrep at four different dose levels compared to a placebo in treating moderate or severe migraines. Participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects of Elismetrep are not specified here but typically could include reactions at the injection site, nausea, dizziness, fatigue, dry mouth, and other common drug-related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
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I've had 2 to 10 severe headaches a month for the last two months.
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I have had migraines for over a year, lasting 4-72 hours without treatment.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, nor plan to become pregnant during the study.
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I have headaches on more than 15 days a month or took headache medicine on more than 10 days a month recently.
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I am on medication to prevent migraines or have a history of certain medical conditions.
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I have low hemoglobin, a blood condition, or am scheduled for surgery/have recently donated blood.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 2 to 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 2 to 48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain freedom
Secondary study objectives
Freedom from Nausea
Freedom from Phonophobia
Freedom from Photophobia
+5 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Elismetrep (K-304) Dose level 4Experimental Treatment1 Intervention
Group II: Elismetrep (K-304) Dose level 3Experimental Treatment1 Intervention
Group III: Elismetrep (K-304) Dose level 2Experimental Treatment1 Intervention
Group IV: Elismetrep (K-304) Dose level 1Experimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention
Find a Location
Closest Location:Alliance for Multispecialty Research· Wichita, KS· 27 miles
Who is running the clinical trial?
Kallyope Inc.Lead Sponsor
4 Previous Clinical Trials
264 Total Patients Enrolled