1500 Participants NeededMy employer runs this trial

Elismetrep for Migraine

Recruiting at 71 trial locations
AV
MC
Overseen ByMichael Crutchlow Kallyope Clinical Director and Medical Monitor, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Kallyope Inc.
Must be taking: Migraine-specific medications
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 trial tests a new treatment called elismetrep for individuals with moderate to severe migraines. The goal is to determine if this medication is safe and effective compared to a placebo (a harmless pill used for comparison). The study includes different groups: some receive a 10 mg dose, others a 20 mg dose, and another group receives the placebo. Individuals who have experienced migraines for over a year, with 2 to 10 moderate or severe attacks per month, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for migraines.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it mentions that any changes to migraine preventive medications should be completed at least 30 days before screening. If you are taking migraine prophylactic medication, the dose should not change during the study.

Is there any evidence suggesting that elismetrep is likely to be safe for humans?

Studies have shown that elismetrep is generally well-tolerated by patients. Research indicates no major safety issues have emerged with its use. Earlier studies revealed no concerning safety problems with elismetrep, suggesting it is safe for most people. While side effects can occur with any treatment, current evidence suggests that elismetrep is safe for treating migraines in clinical trial settings.12345

Why do researchers think this study treatment might be promising for migraine?

Elismetrep is unique because it offers a new approach to treating migraines by targeting specific pathways in the brain that current treatments may not address. Unlike traditional migraine medications such as triptans or NSAIDs that primarily focus on relieving pain and inflammation, Elismetrep is designed to modulate neural pathways involved in migraine onset. Researchers are excited about Elismetrep because it could provide faster relief with potentially fewer side effects, offering hope for patients who do not respond well to existing treatments.

What evidence suggests that elismetrep might be an effective treatment for migraine?

Research has shown that elismetrep can help treat migraines by blocking a specific channel in the body linked to migraine pain. In this trial, participants will receive either a 10 mg or 20 mg dose of elismetrep, or a placebo. Previous studies found elismetrep promising for quickly treating migraines and more effective than a placebo in reducing the number of migraine days each month. These findings suggest that elismetrep could be a useful option for people with moderate to severe migraines.23567

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
See 5 more

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
See 31 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of elismetrep or placebo for the acute treatment of migraine

Single dose
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2, 24, and 48 hours post-dose

48 hours
3 visits (virtual)

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+

TriGemX Bio, Inc.

Lead Sponsor

Citations

TRPM8 Migraine Treatment Shows Promise in Phase 2b ...

Our Phase 2b study demonstrated blocking the migraine-associated TRPM8 channel is effective in the acute treatment of migraine.

New in Cephalalgia Reports! This study offers evidence of ...

Galcanezumab changed cortical thickness after 3- month treatment in the responder group (≥50 % reduction in monthly migraine days) compared to ...

K-554 - Drug Targets, Indications, Patents

We recently reported positive results from a Phase 2b study of elismetrep in the acute treatment of migraine as well as our plan to initiate ...

Elismetrep i Migrän - Kliniska prövningsregister - ICH GCP

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, ...

Canopy Clinical Research Migraine Trial

The researchers analyzed data from nearly 700 adults with various types of migraine, revealing that 28% had received at least one misdiagnosis, ...

Elismetrep Safety Study for Migraine Treatment

A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine This is a long-term safety study to evaluate the safety ...

A real-world study suggests one migraine preventive may be ...

Researchers found that more people saw a meaningful drop in monthly migraine headache days at the three- month mark after starting galcanezumab ...