Table 28Pediatnc Quality of Life Inventory Cerebral Palsy Module Scores, Change From Baseline (Dose per Leg) for Study 141 — ITT Population

AboBoNTA 10 U/kg/leg

(N = 79)

AboBoNTA 15 U/kg/leg

(N = 79)

Placebo

(N = 77)

Score = Daily Activities
At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Score = Eating Activities
At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Score = Fatigue
At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Score = Movement and Balance
At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Score = Pain and Hurt
At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Score = School Activities
At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Score = Speech and Communication
At baseline
 n (%)▬▬▬
 Mean (SD)▬▬▬
Change from baseline to week 12
 n▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬
Change from baseline to end of study
 n (%)▬▬▬
 LS mean (95% CI)▬▬▬
Comparison with placebo
 Difference in LS mean (95% CI)▬▬▬
 P value▬▬▬

aboBoNTA = abobotulinumtoxinA; BoNT = botulinum toxin; CI = confidence interval; LS = least squares; SD = standard deviation.

▬▬▬▬▬

Source: Study 141 Clinical Study Report.22

From: Appendix 4, Detailed Outcome Data

Cover of Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic)
Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet].
Copyright © 2018 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.