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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Elismetrep for Acute Migraine

This is a long-term safety study to measure the whether it is safe and how hard side effects are to live with of intermittent use of elismetrep in the acute treatment of migraine attacks.

Official registry: https://clinicaltrials.gov/study/NCT07674654 · TriGemX Bio, Inc. · enrollment listed as 1,000

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Elismetrep. The registry lists allocation as randomized. This is a long-term safety study to measure the whether it is safe and how hard side effects are to live with of intermittent use of elismetrep in the acute treatment of migraine attacks.

They plan to enroll about 1,000 people at 112 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Elismetrep

Primary outcome (registry wording): Proportion of participants with at least one treatment-emergent adverse event (TEAE)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was \<80%;
  • Participant is able to read, understand, and complete the study questionnaires and diary;
  • 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;
  • Acceptable methods of birth control are:

Public study contact (from the registry)

Annemarie Vance

917-336-3654

annemarie@kallyope.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

112 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07674654 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07674654?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07674654?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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