Table 1.
Cut-off values for the Fatigue Scale for Motor and Cognitive functions (FSMC).
Figure 1.
Flow diagram of the TYNERGY trial.
The CONSORT flow diagram model showing enrolment, follow-up, and data analysis was applied.
Table 2.
Demographics and baseline disease characteristics of the MS patient population included in the TYNERGY study.
Figure 2.
Patient reported fatigue at base line and during the 12 months of natalizumab treatment.
A validated questionnaire for MS, the Fatigue Scale for Motor and Cognitive functions (FSMC) allowing separate evaluations of motor and cognitive aspects of fatigue, was used. The total, motor and cognitive FSMC score at base line and month 3, 6, 9 and 12 are shown. Error bars = Standard Error of the Mean.
Table 3.
Primary end point results: Fatigue as measured by the FSMC; total, motor and cognitive scores and mean change from baseline to month 12 for the ITT population.
Table 4.
Secondary efficacy endpoints displaying significant results; SF-12, ESS, CES-D, PASAT, SDMT, 6MWT and EDSS at baseline and the mean change from baseline to month 12 of the ITT population.