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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Enrollment: 1000

Sponsor: Kallyope Inc.

Location: Central Research Associates, LLC (CRA) dba Flourish Research Birmingham Alabama

Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. 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. 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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07674654). StuddyBuddy aggregates publicly available trial information.