Phase 3
Completed N=2,171
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
Migraine Disorders
Source: ClinicalTrials.gov NCT02565186 ↗
Enrolled (actual)
2,171
Serious AEs
3.2%
Results posted
Aug 2020
Primary outcomePrimary: Number of Participants With at Least 1 Treatment Emergent Adverse Event — 447; 545 Participants
◆ Published Evidence
Emerging
17citations · ~3 / year
Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies.
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.
Linked Publications (5)
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Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies.
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Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies.
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Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain.
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Effect of a change in lasmiditan dose on efficacy and safety in patients with migraine.
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Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least 1 Treatment Emergent Adverse Event |
447; 545 | — |
| SECONDARY Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose |
26.7; 32.2 | — |
| SECONDARY Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose |
37.2; 40.8 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT02565186) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.