Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial

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  • dlt446, dlt446
  • Caroline Roos
  • Lily Qian Li
  • Mika Komori
  • David Ayer
  • Dustin Ruff
  • John Henry Krege

Background: Following the CENTURION phase 3 randomized controlled trial’s four-month double-blind phase, this 12-month open-label extension collected data for up to one year about dose optimization, patterns of use, migraine-related disability, and quality of life during lasmiditan treatment. Methods: Migraine patients ≥18 years completing the double-blind phase and treating ≥3 migraine attacks could continue into the 12-month open-label extension. The initial oral lasmiditan dose was 100 mg; the dose could subsequently be adjusted to 50 mg or 200 mg at the investigator’s discretion. Results: 477 patients entered and 321 (72.1%) completed the extension; 445 (93.3%) treated ≥1 attack with lasmiditan. Of 11,327 attacks, 8654 (76.4%) were lasmiditan-treated (84.9% of these involved moderate or severe pain). By study end, 17.8%, 58.7%, and 23.4% of patients were taking lasmiditan 50, 100, and 200 mg, respectively. Mean improvements were observed in disability and quality of life. The most common treatment-emergent adverse event was dizziness (35.7% of patients, 9.5% of attacks). Conclusions: During this 12-month extension, lasmiditan was associated with a high rate of study completion, most attacks were treated with lasmiditan, and patients reported improvements in migraine-related disability and quality of life. No new safety findings were observed with longer exposure. Trial registration: ClinicalTrials.gov (NCT03670810); European Union Drug Regulating Authorities Clinical Trials Database (EUDRA CT: 2018-001661-17).

OriginalsprogEngelsk
TidsskriftCephalalgia
Vol/bind43
Udgave nummer4
Antal sider11
ISSN0333-1024
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
Medical writing support was provided by Regina E Burris (Syneos Health) and editorial support was provided by Dana Schamberger (Syneos Health). The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by Eli Lilly and Company in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). The authors received no financial support for the research, authorship, and/or publication of this article.

Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by Eli Lilly and Company in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). The authors received no financial support for the research, authorship, and/or publication of this article.

Funding Information:
Caroline Roos is a consultant for Allergan/AbbVie, Eli Lilly and Company, Lundbeck, Novartis, and TEVA. Roos has received honoraria for promotional speaking from Allergan/AbbVie, Eli Lilly and Company, Homeperf, and TEVA. Roos has received research funding from Allergan/AbbVie, Amgen, Eli Lilly and Company, and Lundbeck.

Publisher Copyright:
© The Author(s) 2023.

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