Abstract Details

Title Onset of Efficacy Following Oral Treatment with Lasmiditan for the Acute Treatment of Migraine

Topic Headache

Presentation(s) S17 - Headache: Clinical Trials I (2:06 PM-2:17 PM)

Poster/Presentation
Number 007

Background Lasmiditan is a novel selective 5-HT_1F receptor agonist that lacks vasoconstrictive activity. In two Phase 3 studies, SAMURAI and SPARTAN, lasmiditan met co-primary and secondary efficacy endpoints at 2 hours following initial dose.

Objective To evaluate onset of various efficacy measures following oral lasmiditan for the acute treatment of migraine. The efficacy measures were pain freedom, total migraine freedom (TMF, defined as pain freedom and freedom from associated symptoms), most bothersome symptom (MBS) freedom, pain relief, freedom from associated individual symptoms (photophobia, phonophobia or nausea), and patient reported “no disability” due to migraine.

Design/Methods Integrated analyses were completed from two Phase 3 clinical trials, SPARTAN (NCT02605174) and SAMURAI (NCT02439320). Data was collected at the time of taking lasmiditan (50, 100 or 200 mg) or placebo and every 30 minutes up to 2 hrs, and was analyzed to determine onset of improvement for various efficacy measures.

Results Significantly higher rates of pain-freedom and TMF were achieved starting at 60 minutes in 100mg or 200mg lasmiditan treated groups compared with placebo group (p<0.01). However, rates of photophobia-free, MBS-free, and pain relief were significantly higher starting as early as 30 minutes post-dose, in lasmiditan 100 or 200 mg treated group (p<0.05). 200mg lasmiditan treated group also achieved higher rate of phonophobia-free than placebo starting 30 minutes post-dose (p<0.05). Patients reporting “no disability” due to migraine was significantly greater, starting at 60 minutes, in 200mg lasmiditan treated group (p=0.001). All efficacy measures, except for nausea free, were statistically significant after lasmiditan treatment (50, 100 or 200 mg) compared with placebo at 90 and 120 minutes.

Conclusions Patients treated with lasmiditan for a single migraine attack reported an earlier onset of efficacy compared to placebo. Some of the efficacy measures demonstrated improvement as early as 30 minutes after 100mg or 200mg lasmiditan treatment.

Authors/Disclosures
Erin G. Doty, MD (Eli Lilly and Company) PRESENTER	Dr. Doty has received personal compensation for serving as an employee of Eli Lilly and Company, USA. Dr. Doty has stock in Eli Lilly and Company, USA.
Messoud Ashina, MD, PhD (Dept. of Neurology)	Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. The institution of Dr. Ashina has received research support from The Lundbeck Foundation. Dr. Ashina has received publishing royalties from a publication relating to health care.
Raghavendra Vasudeva, PhD	Dr. Vasudeva has received personal compensation for serving as an employee of Lilly. Dr. Vasudeva has stock in Lilly.
	No disclosure on file
Louise Lombard	Louise Lombard has received personal compensation for serving as an employee of Eli Lilly.
	No disclosure on file
	No disclosure on file
	No disclosure on file

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