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Elismetrep for Migraine

Not yet recruiting at 71 trial locations
MC
Overseen ByMichael Crutchlow Kallyope Clinical Director and Medical Monitor, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Kallyope Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.

Are You a Good Fit for This Trial?

This trial is for people who have moderate or severe migraine attacks. Participants must meet certain health requirements, but specific inclusion and exclusion details are not provided here.

Inclusion Criteria

Voluntarily agrees to participate by giving written informed consent
Be willing and able to comply with study schedule, procedures and restrictions
Be willing to use own personal qualified smartphone to download study-specific eDiary applications
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Exclusion Criteria

Has alanine aminotransferase or aspartate aminotransferase >2.0 X ULN or total bilirubin >1.5 X ULN at screening except isolated bilirubin with normal direct bilirubin
I have brainstem, hemiplegic, or retinal migraines.
Has any other disorder, unwillingness or inability that might jeopardize safety, compliance or interpretation of results in investigator's opinion
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What Are the Treatments Tested in This Trial?

Interventions

  • Elismetrep

Trial Overview

The study compares a new drug called elismetrep to a placebo (inactive treatment) to see how well it works and how safe it is for treating acute migraine. Participants are randomly assigned to receive either the drug or placebo without knowing which one they get.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Elismetrep 20 mgExperimental Treatment1 Intervention
Group II: Elismetrep 10 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kallyope Inc.

Lead Sponsor

Trials
5
Recruited
660+

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