Clinical Trials

Date: 2017-09-09

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the 18th Congress of the International Headache Society (IHC)

Company: Eli Lilly (USA - IN)

Product: lasmiditan

Action mechanism:

• Lasmiditan is an investigational, first-in-class molecule under evaluation for the acute treatment of migraine. Lasmiditan selectively targets 5-HT1F receptors expressed in the trigeminal pathway, and has been designed for the acute treatment of migraine without the vasoconstrictor activity associated with some migraine therapies. Data from SAMURAI, the first of two pivotal Phase 3 studies, was announced in 2016. In March 2017, Lilly completed the acquisition of CoLucid Pharmaceuticals, including lasmiditan, which was originally discovered at Lilly.

Disease: migraine

Therapeutic area: CNS diseases - Neurological diseases

Country: USA

Trial details:

• SPARTAN is a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of three doses of lasmiditan administered orally (50 mg, 100 mg or 200 mg) compared with placebo for the acute treatment of migraine. To be eligible for this trial, patients were required to have at least moderate migraine disability (as measured by a Migraine Disability Assessment Score (MIDAS) ? 11). Patients that participated in the trial had an average of more than five migraine attacks per month at baseline. SPARTAN did not exclude patients with one or more cardiovascular risk factors or known coronary artery disease. The primary endpoint of the study was comparison of the percentage of patients in the lasmiditan 200 mg and placebo groups who were migraine pain-free at two hours following the first dose. The key secondary endpoint of the study was comparison of the percentage of patients in the lasmiditan 200 mg and placebo groups who were free of their MBS (nausea, sensitivity to sound or sensitivity to light) at two hours following the first dose. (NCT02605174)

Latest news:

• • On September 9, 2017, Lilly has presented key primary and secondary endpoint data for lasmiditan, which demonstrated statistically significant improvements compared to placebo in the Phase 3 SPARTAN study. Detailed results have been highlighted at the 18th Congress of the International Headache Society (IHC) in Vancouver.
• At two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo. These results were statistically significant across all three studied doses (50 mg, 100 mg and 200 mg). A statistically significantly greater percentage of patients were also free of their most bothersome symptom (MBS) compared with placebo at two hours. In this study, patients chose their MBS from nausea, sensitivity to sound or sensitivity to light. The majority of patients treated with lasmiditan also experienced relief from migraine pain—classified as mild or no pain—at two hours following the first dose (59 percent for 50 mg, 64.8 percent for 100 mg and 65 percent for 200 mg, p < 0.001 for all dosing groups). These results were statistically significant compared to placebo (47.7 percent). In this study, fewer patients treated with lasmiditan took a second, rescue dose of treatment compared to placebo (41 percent for 50 mg; 32.7 percent for 100 mg; 26.4 percent for 200 mg and 49.8 percent for placebo).
• Lilly will submit the results to a peer-reviewed journal within the next year. An open-label Phase 3 study—GLADIATOR—is also underway evaluating the long-term safety of lasmiditan for the acute treatment of migraine.
• These findings are consistent with SAMURAI, the first pivotal Phase 3 study evaluating the safety and efficacy of lasmiditan for the acute treatment of migraine. Lilly plans to submit a New Drug Application for lasmiditan to the FDA in the second half of 2018.
• • On August 4, 2017, Eli Lilly announced that lasmiditan met its primary endpoint in SPARTAN. At two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo. These results were statistically significant across all three studied doses (50 mg, 100 mg and 200 mg).
• Lasmiditan also met the key secondary endpoint for SPARTAN across all three studied doses, with a statistically significantly greater percentage of patients free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose. In this study, patients chose their MBS from nausea, sensitivity to sound or sensitivity to light.
• At two hours following the first dose of lasmiditan, the percentage of patients who were migraine pain-free was statistically significantly greater compared to placebo in all dosing groups: 28.6 percent for 50 mg (p=0.003); 31.4 percent for 100 mg (p < 0.001); 38.8 percent for 200 mg (p < 0.001) and 21.3 percent for placebo.
• Statistically significantly more patients treated with lasmiditan were also free of their migraine-associated MBS compared to placebo at two hours following the first dose: 40.8 percent for 50 mg (p=0.009); 44.2 percent for 100 mg (p < 0.001); 48.7 percent for 200 mg (p < 0.001) and 33.5 percent for placebo.
• The most commonly-reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea and lethargy.
• These findings are consistent with SAMURAI, the first pivotal Phase 3 study evaluating the safety and efficacy of lasmiditan for the acute treatment of migraine. In this study, lasmiditan met both the primary and key secondary endpoints with statistical significance. Results from SAMURAI were presented at the American Headache Society (AHS) annual meeting in June.
• Lilly now plans to submit a New Drug Application for lasmiditan to the FDA in the second half of 2018. The group will also present detailed data from both studies at scientific meetings and submit the results to peer-reviewed journals within the next year. An open-label Phase 3 study—GLADIATOR—is also underway evaluating the long-term safety of lasmiditan for the acute treatment of migraine.

 

Is general: Yes