Analyses and statistics
SECONDARY
This is a series of three experiments in a double-blind, placebo-controlled, randomized, cross-over design. Exp. I: LTG vs. placebo on group 1, Exp. II: LOV vs. placebo on group 1, Exp. III: LTG vs. placebo on group 2.Sample size: Sample size calculation was done using the primary endpoints, nQuery Advisor, and expected means of MEP amplitudes and standard deviation (SD) for the different measurements from Mainberger et al. [An increase in MEP amplitudes over time is considered to refer to the concept of long-term potentiation (LTP)-like plasticity as it has been demonstrated in Mainberger et al. [Analysis sets: For each experiment, there will be a separate analysis set defined, as it is possible that a patient is suitable for analysis in only one of the first two experiments. All analyses will be performed on the full analysis set (FAS-I, FAS-II, FAS-III), consisting of all patients who delivered a full set of MEP measurements within the corresponding experiment. Since all measurements will take place within a very short time per patient, it is expected that the data will be either complete or entirely missing.Primary endpoint: The primary endpoint analyses will be performed in three separate testing procedures. The global significance level will be 5%. Since experiments I and II are done on the same set of patients, the significance level for those two experiments will each be 2.5%. The significance level of experiment III will be 5%. The primary endpoint analysis will consist of three series of three paired samples two-sidedSecondary endpoints and safety: Analyses of baseline and safety data and secondary endpoints will be done using appropriate descriptive statistics and paired sample tests for difference between the two study groups. All tests will be two-sided with an exploratory significance level of 5%. No adjustment for multiple comparisons will be done.