Table 2

Schedule of activities

ScreeningDouble-blind treatment period (5 days)Safety/follow-up period
ED/visit 1Inpatient admission/visit 2Visit 3Visit 4Visit 5
Day 1Day 1Day 2Day 3Day 4Day 5Day 30Day 90Day 140
Informed consentX        
Review eligibility criteriaX        
RandomisationX        
Medical historyX       X
Concomitant medicationsX        
Physical examX      X 
Neurological examX        
Vital signsX      X 
DemographicsX        
Clinical labs reviewXXXXXX X 
ECG with interpretationX        
Perform pregnancy testX        
VAS assessment XXXXX   
Perform Headache QuestionnairesΨ X     X 
Safety review phone call      X X

  • Ψ: headache questionnaires: MIDAS, HIT-6, WPAI, EQ-5D, DASS-21, ESS.

  • DASS-21, Depression Anxiety Stress Scale; EQ-5D, General Health Status Questionnaire; ESS, Epworth Sleepiness Score; HIT-6, headache impact test; MIDAS, Migraine Disability Scale; VAS, Visual Analogue Scale; WPAI, work productivity and activity impairment.