Bibliographic Details
| Title: |
Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial. |
| Authors: |
Ashina, Messoud1, Roos, Caroline2, Qian Li, Lily3 li_lily_x1@lilly.com, Komori, Mika4, Ayer, David3, Ruff, Dustin3, Krege, John Henry3 |
| Source: |
Cephalalgia. Apr2023, Vol. 43 Issue 4, p1-11. 11p. |
| Subject Terms: |
*MIGRAINE, *DATABASES, *QUALITY of life, *VERTIGO, *CLINICAL trials, *DIZZINESS |
| Company/Entity: |
EUROPEAN Union |
| Abstract: |
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, migrainerelated 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). [ABSTRACT FROM AUTHOR] |
|
Copyright of Cephalalgia is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
Academic Search Complete |
