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Table 2 Schedule of study measurements during the screenings phase and the first treatment set

From: Combined N-of-1 trials to investigate mexiletine in non-dystrophic myotonia using a Bayesian approach; study rationale and protocol

   Mexiletine or placebo (period 1) Wash-out and cross- over Mexiletine or placebo (period 2) Interim analysis 1
Actions Screening Week 1, day 1 Week 2, day 1 Week 3, day 1 Week 4, day 7 Week 5 Week 6, day 1 Week 7, day 1 Week 8, day 1 Week 9, day 7 Week 10 Week 11
Lab test X            
Pregnancy test X            
Consent X            
Medical history X            
ECG X     X      X   
Needle EMG      X      X   
IVR   X X X* X*   X X X* X*   
INQoL/SF-36   X    X   X    X   
Clinical myotonia tests   X    X   X    X   
Quantative grip myotonia   X    X   X    X   
Mexiletine blood plasma levels   X    X   X    X   
Dispense drug/ placebo   X           
Collect medication bottles      X      X   
  1. Study measurements for a possible second, third and fourth treatment set are identical to the measurements in the first treatment set and are not represented in this table.
  2. X* = daily collection of IVR data.