An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

• Status: Completed
• Trial end date: 2019-08-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CoLucid Pharmaceuticals; Eli Lilly and Company
• Collaborator: CoLucid Pharmaceuticals
• Treatments: Lasmiditan

Criteria

Inclusion Criteria:

• Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).

• Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)

• Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).

• Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Exclusion Criteria:

• Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.

• Pregnant or breast-feeding women.

• Women of child-bearing potential not using or not willing to use highly effective contraception.

• Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).

• Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).

• Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).