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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

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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.
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BMC Neurology

ISSN: 1471-2377

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