Elismetrep for Migraine

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

400 Participants Needed

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 to placebo in the treatment of moderate or severe migraine.

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.

What data supports the effectiveness of the drug Elismetrep (K-304) for treating migraines?

Research shows that eletriptan, a drug similar to Elismetrep, is effective in treating acute migraines, suggesting that Elismetrep might also be effective for migraines. ^{1 2 3 4 5}

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of eletriptan in acute migraine: primary care for Excedrin nonresponders. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Craniovascular selectivity of eletriptan and sumatriptan in human isolated blood vessels. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Eletriptan for the acute treatment of migraine in adolescents: results of a double-blind, placebo-controlled trial. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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