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Table 1 Schedule of procedures and visits patient group 1, NS

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

Study overview medication

Base-line (or day 1)

Visit 1 (day 1)

D1

Visit 2 (min. 7—60 D after V 1)

D8–61

Visit 3 (min. 14–60 D after V2)

D22–121

Visit 4 (3 D after V3)

D25–124

Visit 5 (min. 14–60 D after V4)

D39–184

Visit 6 (3 D after V5)

D42–187

 

Exp. I: Lamotrigine (LTG) vs. placebo, single dose (with cross-over)

Exp II: Lovastatin (LOV) vs. placebo 4 days (with cross-over)

Informed consent

X

      

Eligibility criteria

X

      

Demographics

X

      

Medical/surgical history

X

      

Vital signs

X

X

X

X

 

X

 

Pregnancy testa

X

  

X

   

Randomization

 

X

 

X

   

Exp. I: LOV or PLC)

Four days

   

X

X

X

(cross-over)

X

Exp. II: LTG or PLC)

Single dose

 

X

X

(cross-over)

    

TMS (electromyography (EMG) integrated)b

 

X

X

 

X

 

X

TAP

 

X

X

 

X

 

X

Concomitant medication

X

X

X

X

X

X

X

AE/SAE

 

X

X

X

X

X

X

  1. 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
  2. bTMS to be performed 3 h after intake of LOV and 2 h after intake of LTG
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ISSN: 1745-6215