Elismetrep for Migraine

No longer recruiting at 66 trial locations

Overseen By Clinical Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kallyope Inc.

Must not be taking: Opiates, Ergotamine, others

Disqualifiers: Uncontrolled depression, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Single dose with assessments up to 48 hours post-dose

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new drug, elismetrep, for treating moderate to severe migraines. Participants will receive either various doses of elismetrep or a placebo (a harmless pill with no active ingredient) to evaluate the drug's effectiveness. The trial seeks individuals who have experienced migraines for over a year, with 2 to 10 moderate or severe migraine attacks each month. Participants should distinguish their migraines from other types of headaches. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but if you are on migraine prevention medication, your dose should not have changed in the last 3 months, and you should not expect to change it during the study. If you are taking opiates, you must stop at least 14 days before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that elismetrep, the treatment under study for migraines, has been tested in at least one previous study with people. In these studies, researchers gathered information about its safety, indicating that elismetrep has been examined for its effects on humans before, providing some insight into its safety.

However, since this is a Phase 2 trial, it is important to note that the treatment is still under evaluation for safety and effectiveness. Phase 2 trials assess how well people tolerate the treatment and identify any side effects. While some safety information exists, researchers continue to learn more about elismetrep's safety and effectiveness in treating migraines. ^{1 2 3 4 5}

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

Elismetrep is unique because it targets migraine symptoms with a novel mechanism of action, potentially offering relief where traditional treatments like triptans and CGRP inhibitors might not suffice. Unlike most migraine medications, Elismetrep is designed to interact with specific neuronal pathways that could reduce the frequency and intensity of migraines. Researchers are excited about its potential to provide faster and more targeted relief, which could be a game-changer for those who haven’t found success with existing options.

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

Studies have shown that drugs like elismetrep, such as eletriptan, effectively treat sudden migraine headaches. This suggests that elismetrep might also relieve migraines. By targeting specific pathways involved in migraine attacks, elismetrep aims to reduce pain and other symptoms. Although direct research on elismetrep is still developing, its approach appears promising based on knowledge of similar drugs. Participants in this trial will receive one of several dose levels of elismetrep or a placebo to evaluate its effectiveness and safety. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient is able to read, understand and complete the study questionnaires and diary

Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions

Patient voluntarily agrees to participate in the study by giving written informed consent

Exclusion Criteria

I am not pregnant, breastfeeding, nor plan to become pregnant during the study.

I have migraines that fit specific types or started at a certain age.

Patient has history of substance abuse, medication use, or non-compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elismetrep or placebo to evaluate safety and efficacy in treating moderate or severe migraine

Single dose with assessments up to 48 hours post-dose

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elismetrep (K-304)

Trial Overview 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.

How Is the Trial Designed?

Group I: Elismetrep (K-304) Dose level 4 Experimental Treatment 1 Intervention

Group II: Elismetrep (K-304) Dose level 3 Experimental Treatment 1 Intervention

Group III: Elismetrep (K-304) Dose level 2 Experimental Treatment 1 Intervention

Group IV: Elismetrep (K-304) Dose level 1 Experimental Treatment 1 Intervention

Group V: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Kallyope Inc.

Lead Sponsor

Trials

5

Recruited

660+

Published Research Related to This Trial

In a study of 110 patients who did not respond well to Excedrin, a 40-mg dose of eletriptan showed a significant headache response rate of 81% at 2 hours, indicating its effectiveness for treating acute migraines.

Eletriptan was well tolerated, with most adverse effects being mild to moderate and transient, suggesting it is a safe option for patients who have not previously used triptans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eletriptan in acute migraine: primary care for Excedrin nonresponders. Diamond, ML., Hettiarachchi, J., Hilliard, B., et al.[2019]

In the PROMISE-1 study involving 888 adults, intravenous eptinezumab (30 mg, 100 mg, 300 mg) significantly reduced mean monthly migraine days compared to placebo, with effects starting as early as the first day after the initial dose and maintained throughout the year.

Eptinezumab was well tolerated, with no serious safety concerns identified, indicating a favorable safety profile for migraine prevention in adults with episodic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. Smith, TR., Janelidze, M., Chakhava, G., et al.[2021]

In a study of 274 adolescent patients aged 12-17, eletriptan 40 mg did not show a significant difference in immediate 2-hour headache response compared to placebo (57% for both), indicating that its acute efficacy may be limited in this age group.

However, eletriptan demonstrated a significant reduction in headache recurrence within 24 hours (11% for eletriptan vs 25% for placebo) and better sustained headache response rates, suggesting it may be beneficial for longer-term management of migraines in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eletriptan for the acute treatment of migraine in adolescents: results of a double-blind, placebo-controlled trial. Winner, P., Linder, SL., Lipton, RB., et al.[2014]

Eptinezumab was found to be safe and effective for preventing migraines in patients who had previously failed two to four other preventive treatments, as demonstrated in a phase 3b trial.

The study utilized a multi-arm, randomized, double-blind, placebo-controlled design, ensuring robust results that support eptinezumab as a viable option for patients with chronic migraine issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In migraine with previous treatment failures, eptinezumab safely reduced migraine days at 1 to 12 wk. Absher, JR.[2022]

Eletriptan shows a higher selectivity for contracting the middle meningeal artery compared to the coronary artery, indicating a lower risk of adverse coronary side effects at therapeutic doses, which is important for migraine treatment.

Both eletriptan and sumatriptan have similar efficacy in contracting the middle meningeal artery, but eletriptan is less potent in the coronary artery, suggesting it may be safer for patients without coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Craniovascular selectivity of eletriptan and sumatriptan in human isolated blood vessels. MaassenVanDenBrink, A., van den Broek, RW., de Vries, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06848075

Study Details | NCT06848075 | A Phase IIb, Randomized, ... This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the treatment of ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06848075/a-phase-iib-randomized-double-blind-placebo-controlled-study-of-elismetrep-k-304-in-the-treatment-of-migraine

A Phase IIb, Randomized, Double-Blind, Placebo ... This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the treatment of ...

3. withpower.com withpower.com/trial/elismetrep-for-migraine-7cae3

Elismetrep for Migraine · Info for Participants Research shows that eletriptan, a drug similar to Elismetrep, is effective in treating acute migraines, suggesting that Elismetrep might also be effective for ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/sites/books/NBK589548/

Acute Treatments for Episodic Migraine: Surveillance Report 3 Briefly, the report evaluated acute treatments in adult patients with episodic migraine and addressed the following: The comparative effectiveness and harms of ...

5. synapse.patsnap.com synapse.patsnap.com/drug/576d85fc0553473a8419415bcf89b6dd

Elismetrep - Drug Targets, Indications, Patents After 13 weeks, K-757 led to a 1.57% reduction in weight from baseline, while patients who received the duo saw a 2.94% decline; those in the placebo arm had a ...

6. clinicalresearchassociates.com clinicalresearchassociates.com/migraines-k304/

Migraines - K304 - Clinical Research Associates, Inc. We are seeking people like you to participate in a research study for the treatment of migraine headaches.