Interim Trial Results Show Lasmiditan Is Well Tolerated in Migraine Treatment

Researchers found data that showed lasmiditan to be safe in the treatment of migraines.

Lasmiditan is generally well tolerated and demonstrates consistent efficacy for the treatment of acute migraines, according to a study published in Cephalalgia.

In an ongoing prospective, randomized, open-label, phase 3 GLADIATOR (open-label LonG-term safety study of LAsmidDItan in the Acute Treatment Of migRaine) trial (NCT02565186), patients who completed either of 2 double-blind single-attack studies (N=1978) were randomized 1:1 to receive lasmiditan 100 mg (n=963) or 200 mg (n=1015). Patients were instructed to take lasmiditan as the first treatment for new migraine attacks within 4 hours of moderate to severe pain onset that was not improving. A second dose of lasmiditan was allowed for up to 24 hours after the first dose if the migraine attack pain did not respond within 2 hours or the pain recurred after a pain-free period, and no other migraine medication was used.

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Across both treatment groups, pain freedom was observed in 29.6%, most bothersome headache-associated symptom freedom in 39.0%, and pain relief in 56.3% of attacks at 2 hours post-dose, with significantly higher percentages observed in the group taking 200 mg lasmiditan compared with the group taking 100 mg lasmiditan (P <.001).

Nearly half (48.6%) of patients (n=962) reported ≥1 treatment-emergent adverse events (TEAEs) during the study, 86.0% of which were deemed by an investigator to be reasonably or possibly related to lasmiditan treatment. The TEAEs were similar to those in the single-attack studies, including dizziness, somnolence, and paresthesia; the frequency of TEAEs generally decreased with subsequent attacks.

In the group receiving lasmiditan 100 mg, 52.2% of patients (n=503) discontinued treatment due to an adverse event (n=108, 11.2%), noncompliance (n=56, 5.8%), patient request (n=222, 23.1%), investigator request (n=18, 1.9%), sponsor request (n=5, 0.5%), or patients were lost to follow-up (n=94, 9.8%). In the group receiving lasmiditan 200 mg, 51.2% of patients (n=520) discontinued treatment due to an adverse event (n=146, 14.4%), noncompliance (n=53, 5.2%), patient request (n=209, 20.6%), investigator request (n=16, 1.6%), sponsor request (n=9, 0.9%), or patients were lost to follow-up (n=87, 8.6%). A total of 413 patients (42.9%) taking lasmiditan 100 mg and 401 patients (39.5%) taking lasmiditan 200 mg completed 12 months of treatment.

Limitations of this study were the lack of placebo control for comparison in both safety and efficacy results, the high patient drop-out rate, and the likelihood that patients did not necessarily use only lasmiditan to treat all of their migraine attacks. Detailed efficacy information associated with alternative acute treatment was not collected.

This long-term, repeated intermittent dosing data adds to the current evidence that lasmiditan is generally safe and well-tolerated, and demonstrates consistent efficacy for the acute treatment of migraine attacks. Treatment with lasmiditan shows a decrease in migraine disability; further research could be useful in showing the potential of lasmiditan in influencing migraine frequency and severity.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Brandes JL, Klise S, Krege JH, et al. Interim results of a prospective, randomized, open-label, phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study) published online August 21, 2019]. Cephalalgia. doi: 10.1177/0333102419864132