1000 Participants NeededMy employer runs this trial

Elismetrep for Migraine

Recruiting at 113 trial locations
AV
Overseen ByAnnemarie Vance
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Kallyope Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 aims to evaluate the long-term safety and tolerability of elismetrep, a treatment for migraine attacks. Researchers are testing two doses, 10 mg and 20 mg, to observe participants' responses over time. It suits those who completed an earlier trial of elismetrep, experience frequent migraines, and can use a smartphone for daily check-ins. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising migraine treatment.

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

The trial information does not clearly specify if you need to stop taking your current medications. However, it mentions that participants must not violate study requirements for prohibited and permissible medications, so it's best to discuss your current medications with the study team.

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. In earlier studies, many participants used elismetrep without major safety issues. Over 1,000 individuals have taken at least one dose in these trials, and most tolerated it well. The treatment proved safer than a placebo (a pill with no active medicine). While some side effects might occur, they are usually manageable. This ongoing research aims to confirm the long-term safety of elismetrep for migraine relief.12345

Why are researchers excited about this trial's treatments for migraine?

Elismetrep is unique because it targets migraines differently than most current treatments. While common migraine medications often focus on relieving symptoms or constricting blood vessels, Elismetrep uses a new mechanism by specifically targeting the calcitonin gene-related peptide (CGRP) pathway, which is believed to play a key role in migraine attacks. This targeted approach could potentially offer better prevention and fewer side effects. Researchers are excited about Elismetrep because its novel mechanism might provide relief for patients who don't respond well to existing therapies.

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

Research has shown that elismetrep effectively treats migraines, particularly at the 20 mg dose. In studies, 17.6% of participants taking 20 mg of elismetrep experienced complete pain relief, compared to only 9.1% of those taking a placebo. Additionally, 58.8% of those on the same dose reported pain relief, while 42.4% of placebo users experienced relief. The treatment also alleviated other symptoms, with 38.3% of users finding relief from their most bothersome symptom, compared to 24.2% of placebo users. Overall, elismetrep has demonstrated promising results in providing migraine relief.12367

Are You a Good Fit for This Trial?

This trial is for people who have migraines and need treatment when an attack happens. Participants should generally be in good health, but specific inclusion or exclusion details are not provided.

Inclusion Criteria

Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions
Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study
Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary
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Exclusion Criteria

Any change in medical history or laboratory finding since screening in the acute treatment study that renders participant unsuitable for this study as per investigator
Participant at imminent risk of self-harm or harm to others based on clinical interview and Columbia Suicidality Severity Rating Scale (C-SSRS) at base study EoS/Visit 3, including suicidal ideation with intent (Type 4 or 5 on C-SSRS)
At Visit 1, presence of an open/ongoing adverse event from base study EoS visit
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent doses of elismetrep for the acute treatment of migraine attacks

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Elismetrep

Trial Overview

The study is testing the safety of a new migraine medication called elismetrep compared to a placebo (inactive substance) when used as needed for migraine attacks over a long period.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Elismetrep 20 mgExperimental Treatment1 Intervention
Group II: Elismetrep 10 mgExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kallyope Inc.

Lead Sponsor

Trials
5
Recruited
660+

Citations

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 ...

Abstract Details

Response rates for pain relief for elismetrep 20 mg vs. placebo were 58.8% vs. 42.4% (OR=1.9, nominal P=0.0293). There were no serious AEs. At 20 mg, all ...

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 ...

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 ...

Investigational 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 ...

A Long-Term Safety Study of Elismetrep (K-304) in the ...

This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

Elismetrep for Migraine · Info for Participants

Elismetrep (K-304) will have tolerable side effects. If you are taking opiates, you must stop at least 14 days before screening. up to 48 hours post-dose