Elismetrep for Migraine

Recruiting at 66 trial locations

Overseen By Clinical Director

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Kallyope Inc.

Must not be taking: Opiates, Ergotamine, others

Disqualifiers: Uncontrolled depression, Cardiovascular disease, others

Prior Safety Data

Trial Summary

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}

Eligibility Criteria

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

I am between 18 and 70 years old.

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

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

Trial Timeline

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

Treatment Details

Interventions

• Elismetrep (K-304) (Other)

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.

Participant Groups

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+

Findings from Research

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]

References

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]