6.51 ACHIEVEMENT AND MAINTENANCE OF NORMALIZED LEVELS OF EARLY MORNING AND LATE AFTERNOON/EVENING FUNCTIONAL IMPAIRMENT WITH DELAYED-RELEASE AND EXTENDED-RELEASE METHYLPHENIDATE (DR/ER-MPH) IN CHILDREN WITH ADHD: POST HOC ANALYSES OF BEFORE-SCHOOL FUNCTIONING

2019 ◽  
Vol 58 (10) ◽  
pp. S287-S288
Author(s):  
Stephen V. Faraone ◽  
Timothy Wilens ◽  
Ann C. Childress ◽  
Andrew J. Cutler ◽  
Andrea Marraffino ◽  
...  
Keyword(s):  
Functional Impairment ◽  
Extended Release ◽  
Early Morning ◽  
School Functioning ◽  
Children With Adhd ◽  
Late Afternoon ◽  
Delayed Release ◽  
Before School ◽  
Post Hoc

scholarly journals Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate

2021 ◽  
pp. 108705472110200
Author(s):  
Timothy E. Wilens ◽  
Stephen V. Faraone ◽  
Paul G. Hammerness ◽  
Steven R. Pliszka ◽  
Cassandra L. Uchida ◽  
...  
Keyword(s):  
Functional Impairment ◽  
Extended Release ◽  
Early Morning ◽  
Operating Characteristics ◽  
Parent Rating ◽  
Children With Adhd ◽  
Late Afternoon ◽  
Delayed Release ◽  
Before School ◽  
Post Hoc

Objective: The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior–Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful. Method: Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression–Improvement (CGI-I) = 1 and CGI-I ≤ 2. Percentages of participants achieving these thresholds were calculated. Results: Thresholds for CGI-I = 1/CGI-I ≤ 2, respectively, were 27/20 (BSFQ), 5/3 (PREMB-R AM), and 9/5 (PREMB-R PM)-point decreases. More children achieved clinically meaningful improvements with DR/ER-MPH versus placebo (all p < .05). Conclusion: DR/ER-MPH increased proportions of children achieving clinically meaningful improvements in BSFQ and PREMB-R.

scholarly journals 128 Effect of DR/ER-MPH on Early Morning and Late Afternoon/Evening Functioning in Children With ADHD: Analysis of PREMB-R Items From a Phase 3 Trial

CNS Spectrums ◽  
2018 ◽  
Vol 23 (1) ◽  
pp. 80-81
Author(s):  
Steven R. Pliszka ◽  
Valerie K. Arnold ◽  
Andrea Marraffino ◽  
Norberto J. DeSousa ◽  
Bev Incledon ◽  
...  
Keyword(s):  
Early Morning ◽  
Functional Impairments ◽  
Individual Item ◽  
Parent Rating ◽  
Phase 3 ◽  
Double Blind ◽  
Children With Adhd ◽  
Late Afternoon ◽  
Item Scores ◽  
Post Hoc

AbstractObjectiveIn a phase 3 trial of children with ADHD, DR/ER-MPH (formerly HLD200), a delayed-release and extended-release methylphenidate, improved ADHD symptoms and reduced at-home early morning and late afternoon/evening functional impairments versus placebo, as measured by the validated Parent Rating of Evening andMorning Behaviors-Revised, Morning (PREMB-R AM) and Evening (PREMB-R PM) subscales. This post hoc analysis evaluated the effect of DR/ER-MPH versus placebo onindividual PREMB-R AM/PM item scores.MethodData were analyzed from a pivotal, randomized, double-blind, multicenter, placebo-controlled, parallel-group, phase 3 trial of DR/ER-MPH in children (6-12 years) withADHD (NCT02520388). Using the 3-item PREMB-R AM and 8-item PREMB-R PM, both key secondary endpoints, investigators evaluated early morning and lateafternoon/evening functional impairment by scoring each item on a severity scale from 0 (none) to 3 (a lot). For post hoc analyses, treatment comparisons between DR/ER-MPH and placebo at endpoint were determined by using least squares mean changes from baseline on individual PREMB-R AM/PM items score derived from an analysis ofcovariance (ANCOVA) model with treatment as the main effect, and study center and baseline score as covariates.ResultsOf 163 children enrolled across 22 sites, 161 were included in the intent-to-treat population (DR/ER-MPH, n=81; placebo, n=80) and 138 completed the study. The mean DR/ER-MPH dose achieved after 3 weeks of treatment was 68.1 mg. Following 3 weeks of treatment, DR/ER-MPH significantly reduced mean individual item scores from baseline versus placebo on all PREMB-R AM items (all P≤0.002; “getting out of bed”, “getting ready”, and “arguing or struggling in the morning”). Additionally, DR/ER-MPH significantly reduced mean individual item scores from baseline on 5 out of 8 PREMB-R PM items (P<0.01 in 2 items [“sitting through dinner” and “playing quietly”] and P<0.05 in 3 items [“inattentive/distractible”, “transitioning between activities”, and “settling down/getting ready for bed”]). There was a trend towards a reduction on 2 other items of the PREMB-R PM (P<0.09). Distributions of the ratings for each item will be presented. No serious TEAEs were reported; TEAEs were consistent withmethylphenidate.ConclusionsPost hoc analyses revealed that DR/ER-MPH significantly reduced all PREMB-R AM item scores, including “getting out of bed”, and many PREMB-R PM items, including “getting ready for bed” in children with ADHD. These findings are worth further exploration.Funding AcknowledgementsIronshore Pharmaceuticals & Development, Inc.

130 Consistent Efficacy of DR/ER-MPH on Early Morning Functioning in Children With ADHD: Analysis of BSFQ Item Ratings From a Pivotal Phase 3 Trial

CNS Spectrums ◽  
2018 ◽  
Vol 23 (1) ◽  
pp. 82-82
Author(s):  
Timothy E. Wilens ◽  
Steven R. Pliszka ◽  
Valerie K. Arnold ◽  
Andrea Marraffino ◽  
Norberto J. DeSousa ◽  
...  
Keyword(s):  
Early Morning ◽  
Analysis Of Covariance ◽  
Phase 3 ◽  
Pivotal Phase ◽  
Double Blind ◽  
Children With Adhd ◽  
Item Scores ◽  
Before School ◽  
Treatment Comparisons ◽  
Post Hoc

AbstractObjectiveIn a phase 3 trial of children with attention-deficit/hyperactivity disorder (ADHD), DR/ER-MPH (formerly HLD200), a delayed-release and extended-release methylphenidate, improved ADHD symptoms and reduced at-home early morning and late afternoon/evening functional impairment versus placebo. The validated Before School Functioning Questionnaire (BSFQ), a key secondary endpoint, was used to measure early morning functional (EMF) impairment. This post hoc analysis evaluated the effect of DR/ER-MPH versus placebo on individual BSFQ item scores from baseline.MethodData were analyzed from a pivotal, randomized, double-blind, multicenter, placebo-controlled, parallel-group, phase 3 trial of DR/ER-MPH in children (6-12 years) withADHD (NCT02520388). Using the 20-item BSFQ, investigators evaluated EMF impairment by scoring each item on a severity scale of 0 to 3, with 0 denoting “no impairment” and 3 denoting “severe impairment”. For post hoc analyses, treatment comparisons between DR/ER-MPH and placebo at endpoint were determined by using least squares mean changes from baseline on individual BSFQ items score derived from an analysis of covariance (ANCOVA) model with treatment as the main effect, and study center and baseline score as covariates.ResultsOf 163 children enrolled across 22 sites, 161 were included in the intent-to-treat population (DR/ER-MPH, n=81; placebo, n=80) and 138 completed the study. The mean DR/ER-MPH dose achieved after 3 weeks of treatment was 68.1 mg. Following 3 weeks of treatment, DR/ER-MPH significantly reduced mean BSFQ item scores frombaseline on 18 out of 20 items versus placebo (P<0.001 in 8 items [listening, following directions, attention, forgetfulness, talkativeness, silliness, time awareness, getting to school]; P<0.01 in 7 items [overall organization, being quiet, distraction, interrupt/blurt out, breakfast, hygiene, independence]; P<0.05 in 3 items [procrastination, hyperactivity, awaiting turn]). Only “dressing” and “misplacing/losing items” showed no significant between-group differences (P=0.171 and P=0.175, respectively). Distributions of the severity ratings for each item will be presented. No serious TEAEs were reported; TEAEs were consistent with methylphenidate.ConclusionsPost hoc analyses revealed that DR/ER-MPH significantly reduced 18 out of 20 individual BSFQ item scores versus placebo in children with ADHD. These findings are worth further exploration.Funding AcknowledgementsIronshore Pharmaceuticals & Development, Inc.

5.21 POST HOC META-ANALYSIS OF MORNING AND EVENING BEHAVIORS IN CHILDREN WITH ADHD TREATED WITH DELAYED-RELEASE AND EXTENDED-RELEASE METHYLPHENIDATE FROM TWO PHASE 3 STUDIES

2020 ◽  
Vol 59 (10) ◽  
pp. S155-S156
Author(s):  
Steven R. Pliszka ◽  
Ann Catherine Childress ◽  
Andrew J. Cutler ◽  
Andrea Marraffino ◽  
Norberto J. DeSousa ◽  
...  
Keyword(s):  
Extended Release ◽  
Meta Analysis ◽  
Phase 3 ◽  
Two Phase ◽  
Children With Adhd ◽  
Delayed Release ◽  
Post Hoc

Reliability and Validity of the Before-School Functioning Scale in Children With ADHD

2015 ◽  
Vol 22 (11) ◽  
pp. 1040-1048 ◽  
Author(s):  
Stephen V. Faraone ◽  
Paul G. Hammerness ◽  
Timothy E. Wilens
Keyword(s):  
Reliability And Validity ◽  
School Functioning ◽  
Good Test ◽  
Children With Adhd ◽  
Treatment Data ◽  
Pre Treatment ◽  
Internal Homogeneity ◽  
Before School ◽  
Test Retest Reliability ◽  
Adhd Medications

Objective: Children with ADHD frequently manifest behavioral difficulties in the morning prior to school. We sought to assess the reliability and validity of the Before-School Functioning Questionnaire (BSFQ) as a measure of morning behaviors impaired by ADHD. Method: We used pre-treatment data from a randomized crossover study of 6- to 12-year-old participants comparing the methylphenidate transdermal delivery system (MTS) with a placebo transdermal system (PTS) for a total of 4 weeks. Results: The BSFQ investigator–rated scale shows very good internal homogeneity (Cronbach’s α = .91), good test–retest reliability ( r = .60), good concurrent validity ( r range = .42-.86), and a strong treatment effect (effect size = −.93). The self-rated BSFQ showed lower levels of reliability and validity. Conclusion: The investigator-rated BSFQ should be used in future trials of ADHD medications aimed at assessing efficacy in the morning before school.

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