PMC:3605436 / 11794-13861 JSONTXT

{"project":"NEUROSES","denotations":[{"id":"T237","span":{"begin":12,"end":21},"obj":"PATO_0002532"},{"id":"T238","span":{"begin":352,"end":361},"obj":"PATO_0002532"},{"id":"T239","span":{"begin":75,"end":79},"obj":"PATO_0001309"},{"id":"T240","span":{"begin":75,"end":79},"obj":"PATO_0000165"},{"id":"T241","span":{"begin":632,"end":639},"obj":"PATO_0000461"},{"id":"T242","span":{"begin":1535,"end":1542},"obj":"PATO_0000461"},{"id":"T243","span":{"begin":865,"end":870},"obj":"PATO_0000008"},{"id":"T244","span":{"begin":921,"end":931},"obj":"PATO_0000990"},{"id":"T245","span":{"begin":1006,"end":1013},"obj":"CHEBI_38960"},{"id":"T246","span":{"begin":1152,"end":1159},"obj":"CHEBI_38960"},{"id":"T247","span":{"begin":1019,"end":1022},"obj":"CHEBI_52027"},{"id":"T248","span":{"begin":1564,"end":1567},"obj":"CHEBI_52027"},{"id":"T249","span":{"begin":1183,"end":1188},"obj":"PATO_0000586"},{"id":"T250","span":{"begin":1757,"end":1762},"obj":"CHEBI_35209"},{"id":"T251","span":{"begin":571,"end":581},"obj":"PM3425"},{"id":"T252","span":{"begin":665,"end":675},"obj":"PM3425"},{"id":"T253","span":{"begin":734,"end":744},"obj":"PM3425"},{"id":"T254","span":{"begin":819,"end":829},"obj":"PM3425"},{"id":"T255","span":{"begin":571,"end":581},"obj":"PM3425"},{"id":"T256","span":{"begin":665,"end":675},"obj":"PM3425"},{"id":"T257","span":{"begin":734,"end":744},"obj":"PM3425"},{"id":"T258","span":{"begin":819,"end":829},"obj":"PM3425"}],"text":"Analyses of secondary efficacy endpoints\nThe total FSMC score changed in a time dependent manner, with the greatest improvement during the first three months of natalizumab treatment. The mean individual FSMC motor and cognition scores were improved by 4.86 and 3.97 from baseline values of 37.3 and 33.9, respectively (p\u003c0.0001; Table 3, Fig. 1).\nThe secondary variables HRQoL, SF-12,ESS, CES-D, PASAT, and SDMT, EDSS, and 6MWT all showed significant improvement from baseline to month 12 and the data are shown in Table 4. It is notable that the reduction of the CES-D depression score indicated that the patents improved from an average of 18.3 (equals moderate depression) before start of natalizumab treatment to 14.2 (equals no depression) after 12 months of treatment. The 6 months results of HRQoL, sleepiness, depression, cognition, disability and walking speed were all highly significant (p\u003c0.0008–0.0001) and consistent with the results at 12 months (data not shown). The results from the step-counter test did not show any significant change in the amount of walking from baseline to months 6 or 12. The compliance for the use of the step-counter was poor, leading to a large loss of data and no meaningful conclusions could be drawn from this analysis (data not shown). The CWQ data showed no significant change when measured as overall change in all participating countries although certain data regarding this parameter appeared promising and will be analysed further (data not shown). The majority of the patients (on average 92.6% at each visit) did not receive any fatigue medication throughout the trial, and there were no changes in fatigue-related medication during the trial. The safety profile in the study was comparable to current label for natalizumab.\n10.1371/journal.pone.0058643.t004 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. ITT: Intention to treat, CI: Confidence Interval.\n\nS"}