Table 8.
Summary of the phase II and phase III clinical trials performed to date with lasmiditan
| Study ID | Administration | Summary | Participants (received lasmiditan) | Status | Date started–finished | Reference |
|---|---|---|---|---|---|---|
| Phase II | ||||||
| COL MIG-201 | Intravenous | Randomised, multicentre, placebo-controlled, double-blind, group-sequential, adaptive treatment-assignment, proof-of-concept and dose-finding study in the acute treatment of migraine | 130 (88) | Completed | 2006–2007 | [63, 73–75] |
| COL MIG-202 | Single oral (50, 100, 200 or 400 mg) | Randomised, multicentre, placebo-controlled, double-blind, parallel-group, dose-ranging outpatient study in the acute treatment of migraine | 512 (86) | Completed | 2009–2010 | [63, 76, 77] |
| Phase III | ||||||
| COL MIG-301 (SAMURAI) | Single oral tablet (100 or 200 mg) | Prospective, randomised, double-blind, placebo-controlled study in subjects with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11) | 2231 (617) | Completed | 2015–2016 | [78] |
| COL MIG-302 (SPARTAN) | Single oral tablet (50, 100 or 200 mg) | Prospective, randomised, double-blind, placebo-controlled study in subjects with disabling migraine (MIDAS score ≥ 11) | 3007 | Ongoing, not recruiting | 2016–2017 | [79] |
| COL MIG-305 (GLADIATOR) | Single oral tablet with second dose for rescue (100 or 200 mg) | Prospective, randomised, open-label study in subjects with migraine who have completed COL MIG-301 or COL MIG-302 to evaluate the safety, tolerability and efficacy of long-term intermittent use of lasmiditan 100 mg and 200 mg as the first and second dose for the acute treatment of migraine | 2580* | Recruiting | 2015–2018* | [80] |
*Indicates estimated enrolment or estimated finishing date