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10.12.20

Lasmiditan Treatment Provides Pain Freedom At 2 Hours in at Least 2 of 3 Migraine Attacks in New Phase 3 Study

  • KEYWORDS:
  • Headache
  • Lasmiditan
  • Migraine
  • Phase 3 clinical trial

In the phase 3 CENTURION study, participants treated with lasmiditan (Reyvow; Eli Lilly, Indianapolis, IN) for migraine attacks, doses of 100 mg or 200 mg, had 3.8 and 7.2 times greater odds of achieving pain freedom at 2 hours post treatment compared with placebo in at least 2 out of 3 attacks. 

Study results show that participants taking lasmiditan 200 mg had 7.2 times greater odds of achieving pain freedom at 2 hours in at least 2 of 3 migraine attacks than those on placebo (24.4% vs 4.3%; odds ratio: 7.2; P<.001), with a therapeutic gain of approximately 20%. Participants who took lasmiditan 100 mg had 3.8 times greater odds of achieving pain freedom at 2 hours in at least 2 of 3 attacks than study participants on placebo (14.4% vs. 4.3%; P<.001), translating to a therapeutic gain for participants taking lasmiditan of approximately 10%. 

Nearly 2 out of 3 participants taking lasmiditan achieved pain relief at 2 hours in at least 2 of 3 attacks, including 66.7% and 62.3% of those taking lasmiditan 200 mg and 100 mg compared with 36.9% of those on placebo (P<.001 for each lasmiditan comparison with placebo).

Many participants taking lasmiditan were pain-free at 2 hours in at least 2 of 3 migraine attacks, 20.1% for lasmiditan 200 mg and 11% for lasmiditan 100 mg, compared with placebo (4.3%) (P<.001 for each lasmiditan comparison to placebo). Nearly 2 out of 3 participants taking lasmiditan 200 mg (62.7%) and more than half of participants taking 100 mg (55.6%) achieved pain relief at 2 hours in at least 2 of 3 migraine attacks compared to 1 out of 3 participants (33.6%) on placebo (P<.001 for each lasmiditan comparison with placebo).

In the study, the efficacy and safety of lasmiditan was assessed, including consistency of the participants’ response to treatment across 4 migraine attacks. The study enrolled 1,471 participants with migraine who were randomly assigned to receive at least 1 dose of either lasmiditan 200 mg (n=486), lasmiditan 100 mg (n=485) or control treatment (placebo for some but not all attacks, n=500) per attack.

Study participants treated a migraine attack when their pain was at least of moderate severity and within 4 hours after pain onset. 
The most common adverse events are falling asleep during daily activities, dizziness, dyskinesia, hallucinations and delusions, and unusual urges.
 

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