Migraine: extension study supports lasmiditan safety, efficacy

  • Brandes JL & al.
  • Cephalalgia
  • 21 Aug 2019

  • International Clinical Digest
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Takeaway

  • Interim results from a long-term, open-label, phase 3 trial show that intermittent lasmiditan 100 and 200 mg are generally well tolerated and efficacious for acute treatment of migraine.

Why this matters

  • Long-term data are consistent with the favorable safety and efficacy profile observed in single-attack phase 3 studies.

Study design

  • GLADIATOR is a prospective, randomised, open-label, phase 3 study of 2116 patients with migraine who completed the single-attack SAMURAI/SPARTAN phase 3 trials.
  • Treatment: ≥1 dose of lasmiditan 100 mg (n=963)/200 mg (n=1015) intermittently up to 1 year.
  • Funding: Eli Lilly and Company.

Key results

  • 19,058 migraine attacks were treated; no deaths were reported.
  • Treatment-emergent adverse events (TEAEs), mild to moderate: 100 mg, 45.1%; 200 mg, 52%.
  • No cardiovascular (vasoconstriction) TEAEs were observed.
  • No TEAEs occurred in >1 patient; none were lasmiditan related, according to investigators.
  • Treatment of ≥5 migraine attacks showed decreased incidences across attacks 1-5.
  • Discontinuations related to AEs: 100 mg, 11.2%; 200 mg, 14.4%.
  • Dizziness was the most common AE for discontinuation: 100 mg, 2.7%; 200 mg, 4.3%.
  • At 2 hours postdose, pain freedom was noted in 26.9% and 32.4% of the attacks with 100 and 200 mg lasmiditan, respectively.

Limitations

  •  Lack of placebo control.

Coauthored with Chitra Ravi, MPharm