|  | 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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pregnancy test | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
ECG | X | Â | Â | Â | X | Â | Â | Â | Â | X | Â | Â |
Needle EMG | Â | Â | Â | Â | X | Â | Â | Â | Â | X | Â | Â |
IVR | Â | X | X | X* | X* | Â | X | X | X* | X* | Â | Â |
INQoL/SF-36 | Â | X | Â | Â | X | Â | X | Â | Â | X | Â | Â |
Clinical myotonia tests | Â | X | Â | Â | X | Â | X | Â | Â | X | Â | Â |
Quantative grip myotonia | Â | X | Â | Â | X | Â | X | Â | Â | X | Â | Â |
Mexiletine blood plasma levels | Â | X | Â | Â | X | Â | X | Â | Â | X | Â | Â |
Dispense drug/ placebo | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Collect medication bottles | Â | Â | Â | Â | X | Â | Â | Â | Â | X | Â | Â |