Prevention of medication overuse and medication overuse headache in patients with migraine: a randomized, controlled, parallel, allocation-blinded, multicenter, prospective trial using a mobile software application

Table 1 Table of scheduled activities

Tasks	Screening	Baseline	Visit 1^a	Visit 2^a	Visit 3 End of trial/early withdrawal
Tasks	28 days prior to randomization	Day 0	Day 112 ± 7 days	Day 224 ± 7 days	Day 336 ± 7 days
Informed consent^b	X
Inclusion/exclusion criteria	X	X
Assessment of compliance with the app		X	X	X	X
Current headache treatment	X	X	X	X	X
Concomitant medication/supplement check	X	X	X	X	X
Randomization		X
Medical history	X		X	X	X
Clinical data/additional lifestyle factors		X
MIDAS		X			X
DASS		X			X
Assessment of headache days	Continuously via app
Assessment of headache episodes	Continuously via app
Confirmation of app-based outcome event assessment			X	X	X
SAE assessment		X	X	X	X

^aStudy visit 1 and visit 2 can exceptionally be conducted via a phone call if local regulations (e.g., due to a pandemic such as SARS-CoV-2) prohibit a personal study visit
^bInformed consent has to be obtained prior to any study-related procedures at the screening visit
DASS Depression, Anxiety and Stress Scale, MIDAS Migraine-specific disability assessment

ISSN: 1745-6215