Table 3

SMITE study objectives and end-points

ObjectivesEndpoints
To evaluate the effect of eptinezumab compared with intravenous lignocaine in aborting status migrainosus

  • Time from infusion to discharge (Primary outcome)

  • Duration of symptoms post infusion

  • Visual Analogue Scale (VAS) on discharge or at day five (primary outcome)

  • Change in VAS from admission to discharge (primary outcome)

  • Use of rescue therapies during the 5-day admission (primary outcome)

  • Pain freedom at 2 hours (secondary outcome)

  • Freedom from most bothersome symptom at 2 hours (secondary outcome)

  • Sustained pain freedom at 24 hours postinfusion in patients who achieve pain freedom (secondary outcome)

To explore the effect of eptinezumab compared with lignocaine on the change from baseline in health resource utilisation

  • Change from baseline in monthly number of primary healthcare provider visits (secondary outcome)

  • Change from baseline in monthly emergency department visits (secondary outcome)

To evaluate the effect of eptinezumab compared with intravenous lignocaine on patient reported outcomes of migraine related disability

  • Change from baseline in MIDAS (secondary outcome)

  • Change from baseline HIT-6 (secondary outcome)

  • Change from baseline in WPAI (secondary outcome)

  • Change from baseline in EQ-5D (secondary outcome)

To evaluate the safety and tolerability of eptinezumab in subjects with status migrainosus

  • Adverse events (other safety outcome)

  • Clinical laboratory values and vital signs (secondary outcome)

  • EQ-5D, General Health Status Questionnaire; HIT6, headache impact test; MIDAS, Migraine Disability Scale; SMITE, Status migrainosus inpatient treatment with eptinezumab; WAPI, work productivity and activity impairment.