Improvement of synaptic plasticity and cognitive function in RASopathies—a monocentre, randomized, double-blind, parallel-group, placebo-controlled, cross-over clinical trial (SynCoRAS)

Table 2 Schedule of procedures and visits patient group 2, NF1

Study overview medication	Baseline visit (or day 1)	Visit 1 (day1) D1	Visit 2 (7–60 days after V 1) D8–61
Study overview medication		Exp. III: Lamotrigin (LTG) or Placebo
Informed consent	X
Eligibility criteria	X
Demographics	X
Medical/surgical history	X
Vital signs	X	X
Pregnancy test^a	X	X
Randomization		X
Exp. III: LTG or PLC) Single dose		X	X (cross-over)
TMS (EMG integrated)^a		X	X
TAP		X	X
Concomitant medication	X	X	X
AE/SAE		X	X

^aTo be performed after having obtained informed consent; if baseline is less than 5 days prior to V1, a second pregnancy test is not necessary
^bTMS to be performed 2 h after intake of LTG

ISSN: 1745-6215