Back to search results

Long-Term Safety Study of Elismetrep for Migraine

This study is looking at the long-term safety of Elismetrep (K-304) for treating acute migraine attacks. You might be able to join if you have already completed a previous study of Elismetrep (Study K-304 P003) and met certain requirements in that study. Researchers want to see how many participants experience side effects (treatment-emergent adverse events or TEAEs), serious side effects (SAEs), or need to stop taking the study drug because of side effects. The study plans to enroll about 1000 people and is currently unclear about its recruitment status. You will receive either Elismetrep or a placebo (an inactive substance).

Study design
This is an interventional study planning to enroll 1000 participants. It compares Elismetrep to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07674654

A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
Kallyope Inc.
~1,000 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:ElismetrepPlacebo

At a glance

Recruiting sites
0 of 115 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
Measured over Through study completion, an average of 1 year
+3 more outcomes measured

Conditions

Acute Migraine

Explore related trials

Acute migraine

Where it's being run

115 sites across 35 states
California18
Texas10
Nevada7
New York7
Utah6
Missouri5
North Carolina5
Pennsylvania5

Who to contact

Annemarie Vance
[email protected]
917-336-3654
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.

What this trial measures

  • Proportion of participants with at least one treatment-emergent adverse event (TEAE)Through study completion, an average of 1 year
  • Proportion of participants with at least one treatment-emergent serious adverse event (SAE)Through study completion, an average of 1 year
  • Proportion of participants with TEAEs leading to study drug discontinuationThrough study completion, an average of 1 year
  • Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment armThrough study completion, an average of 1 year