Elismetrep for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called elismetrep to determine its effectiveness and safety for people with migraines. Participants will receive either a low dose, a higher dose of the treatment, or a placebo for comparison. The goal is to discover if elismetrep can reduce migraine symptoms. Individuals who have experienced migraines with or without aura for at least a year, with 2 to 10 moderate or severe attacks per month, may be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking migraine treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are taking migraine preventive medication, you should not change the dose during the study, and any withdrawal should be completed at least 30 days before screening. Also, you cannot use prescription opiates within 14 days of screening or during the study.
Is there any evidence suggesting that elismetrep is likely to be safe for humans?
Research has shown that elismetrep is generally safe for treating migraines. Previous studies found that people usually tolerate this treatment well, with most side effects being mild and temporary. Participants reported tingling, flushing, or a warm sensation. Importantly, no major safety concerns have emerged.
In one study, common side effects for those taking a 20 mg dose included tingling in the mouth (9.8%), feeling hot (9.8%), tingling sensations (7.8%), hot flushes (7.8%), and general flushing (5%). This information suggests that the treatment could be a promising option for migraine relief, with manageable side effects.12345Why do researchers think this study treatment might be promising for migraine?
Elismetrep is unique because it targets migraines by modulating calcitonin gene-related peptide (CGRP) receptors. Unlike traditional migraine treatments that often rely on triptans or pain relievers, Elismetrep works by a different mechanism, potentially offering relief for those who don't respond to current options. Researchers are particularly excited about its potential to provide fast and effective relief with fewer side effects, making it a promising alternative for migraine sufferers.
What evidence suggests that elismetrep might be an effective treatment for migraine?
Research has shown that elismetrep may help treat migraines. In one study, 17.6% of patients taking a 20 mg dose of elismetrep became pain-free, compared to 9.1% of those taking a placebo. Another study found that the 20 mg dose provided better overall pain relief and improvement than a placebo. Elismetrep blocks a protein called TRPM8, believed to be involved in migraine pain. These findings suggest that elismetrep could be an effective option for people dealing with migraines.12356
Are You a Good Fit for This Trial?
This trial is for women with migraines who are either past menopause, have had certain surgeries (like removal of ovaries or uterus), or can become pregnant but agree to use reliable birth control during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Elismetrep or placebo for the acute treatment of migraine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elismetrep
Trial Overview
The study compares a new drug called elismetrep to a placebo (inactive pill) to see how well it works and how safe it is for treating migraine attacks. Participants are randomly assigned and neither they nor the researchers know which treatment they're getting.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kallyope Inc.
Lead Sponsor
Citations
Kallyope's Phase 2b Study of Elismetrep, A Novel ...
Overall, elismetrep showed dose- and time-dependent efficacy with the 20-mg dose providing the greatest effects (see graphs). oral paresthesia ...
2.
neurologylive.com
neurologylive.com/view/investigational-trpm8-antagonist-elismetrep-achieves-positive-phase-2b-data-acute-migraineInvestigational TRPM8 Antagonist Elismetrep Achieves ...
New data from a phase 2b trial showed that elismetrep showed favorable efficacy and safety outcomes compared with placebo, supporting its ...
Elismetrep Found Safe and Effective for Treating Migraine
Response rates for freedom from pain with elismetrep 20 mg versus placebo were 17.6% and 9.1%, respectively, in primary analyses. Overall, the ...
Elismetrep for Migraine · Info for Participants
a 40-mg dose of eletriptan showed a significant headache response rate of 81% at 2 hours, indicating its effectiveness for treating acute migraines.
The comparative effectiveness of migraine preventive drugs
Fifty-seven trials with 26,378 patients reported on 50% or more reduction in monthly migraine days and could be incorporated into the network meta-analysis [11, ...
A Long-Term Safety Study of Elismetrep (K-304) in the Acute ...
This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine ...
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