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Chemistry; Chem Sci/Eng | | English term or phrase: ABC factor scores | | muchas gracias! |
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 Alistair Ian Spearing Ortiz
Local time: 05:54
| Grading comment gracias!!
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| Jan 27 - Changes made by Yana Dovgopol: | | Term Context | o Change from baseline in symptoms as measured by the: ABC total, ABC factor scores, ADAMS total, ADAMS factors scores, and Social Responsiveness Scale (SRS)
In this framework, measures of efficacy were obtained. It is important to note that the study was not designed to address an efficacy hypothesis as evidenced by the presence of ascending dose cohorts and a sample size not powered to differentiate efficacy endpoints. These exploratory findings showed no statistically significant differences in the efficacy parameters between RO4917523 and placebo in ABC, RBANS, and CGI-S measures of efficacy. However, an improvement in symptoms measured by the ADAMS total score was observed in the overall RO4917523 dose group versus placebo (ANOVA, p<0.1). The greatest magnitudes of change were seen in the RO4917523 0.1 and 0.5 mg/day dose groups, as evidenced by the difference to placebo in the reduction from baseline ADAMS total score [90% CI] of -10.67 [-19.20,-2.13] and -9.12 [-16.40,-1.84], respectively. Further examination of these findings in a per protocol analysis revealed that the effects were observed in the following ADAMS factor scores: Manic/Hyperactivity and Depressed Mood in the overall RO4917523 dose group versus placebo (ANOVA, p<0.1). Additionally, there was a trend toward improvement in the ADAMS Social Avoidance factor (ANOVA, p=0.215). Noteworthy is that hyperactivity and social avoidance have been described as core symptoms in patients with FXS. Furthermore, a higher proportion of RO4917523 treated than placebo-treated patients met criteria for response, defined as an improvement in the ABC by ≥25% plus an improvement ≥1 on the CGI-S. Therefore, based on the neurodevelopmental nature of the disorder, the mechanism of action (based on ‘the mGlu5 Theory of FXS’), the observed safety and tolerability, and the discussed trends in efficacy in an adult population with FXS (18 years of age and older), we propose to evaluate FXS patients in an adequately powered trial designed to evaluate the safety and efficacy of RO4917523 that also includes patients between 16 to 17 years of age.
muchas gracias! => muchas gracias! |
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