PMID- 34714120
OWN - NLM
STAT- MEDLINE
DCOM- 20211210
LR  - 20211214
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Linking)
VI  - 31
IP  - 9
DP  - 2021 Nov
TI  - A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and 
      d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity 
      Disorder.
PG  - 597-609
LID - 10.1089/cap.2021.0077 [doi]
AB  - Objectives: To evaluate the efficacy and safety of once-daily 
      serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) capsules (Azstarys()) 
      compared with placebo in children with attention-deficit/hyperactivity disorder 
      (ADHD) in a randomized, double-blind, dose-optimized laboratory classroom study. 
      Methods: Children ages 6-12 with ADHD were enrolled. During a 3-week, open-label, 
      Dose Optimization Phase, subjects initiated treatment with 39.2 mg/7.8 mg/day of 
      SDX/d-MPH and were titrated weekly to an optimal dose (maximum dose of 
      52.3/10.4 mg). During the double-blind Treatment Phase, subjects were randomized 
      to receive their optimal dose of SDX/d-MPH or placebo for 7 days. On day 7, 
      efficacy was assessed in the laboratory classroom using the Swanson, Kotkin, 
      Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of 
      Performance (PERMP). To evaluate safety, adverse events (AEs), vital signs, and 
      electrocardiograms were assessed, and suicide risk was assessed. Results: A total 
      of 149 subjects completed the study. In the primary efficacy analysis, the mean 
      postdose change from baseline in SKAMP-Combined scores averaged over the 
      laboratory classroom day was significantly improved with SDX/d-MPH versus placebo 
      (least-squares mean treatment difference [95% confidence interval]: -5.41 [-7.10 
      to -3.71]; p < 0.001). A significant treatment effect for SDX/d-MPH compared with 
      placebo was observed from 1 to 10 hours postdose. A post hoc analysis more 
      comparable with that conducted in similar studies indicated a 0.5- to 13-hour 
      onset and duration of efficacy. Both average postdose PERMP-Attempted and 
      PERMP-Correct score changes from baseline were significantly improved among those 
      treated with SDX/d-MPH versus placebo (p < 0.001 for both). No serious AEs were 
      reported. During the Dose Optimization Phase, two-thirds of subjects reported 
      AEs; the most common being insomnia and decreased appetite. Conclusions: 
      SDX/d-MPH showed significant improvement in ADHD symptoms compared with placebo 
      in children 6-12 years of age, with a rapid onset and extended duration of 
      treatment effect. SDX/d-MPH was safe, with AEs comparable with those observed 
      with other stimulant treatments.
FAU - Kollins, Scott H
AU  - Kollins SH
AD  - Duke ADHD Program, Durham, North Carolina, USA.
AD  - Holmusk, Durham, North Carolina, USA.
FAU - Braeckman, Rene
AU  - Braeckman R
AD  - KemPharm, Inc., Celebration, Florida, USA.
FAU - Guenther, Sven
AU  - Guenther S
AD  - KemPharm, Inc., Celebration, Florida, USA.
FAU - Barrett, Andrew C
AU  - Barrett AC
AD  - KemPharm, Inc., Celebration, Florida, USA.
FAU - Mickle, Travis C
AU  - Mickle TC
AD  - KemPharm, Inc., Celebration, Florida, USA.
FAU - Oh, Charles
AU  - Oh C
AD  - Corium, Inc., Grand Rapids, Michigan, USA.
FAU - Marraffino, Andrea
AU  - Marraffino A
AD  - Meridien Research, Maitland, Florida, USA.
FAU - Cutler, Andrew J
AU  - Cutler AJ
AD  - SUNY Upstate Medical University, Syracuse, New York, USA.
AD  - Neuroscience Education Institute, Lakewood Ranch, Florida, USA.
FAU - Brams, Matthew N
AU  - Brams MN
AD  - Bayou City Research, Houston, Texas, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20211029
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Capsules)
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (serdexmethylphenidate and dexmethylphenidate)
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
MH  - *Attention Deficit Disorder with Hyperactivity/drug therapy
MH  - Capsules/therapeutic use
MH  - *Central Nervous System Stimulants/adverse effects
MH  - Child
MH  - Delayed-Action Preparations/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Humans
MH  - Laboratories
MH  - *Methylphenidate/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - ADHD
OT  - SDX/d-MPH
OT  - pediatric
EDAT- 2021/10/30 06:00
MHDA- 2021/12/15 06:00
CRDT- 2021/10/29 12:15
PHST- 2021/10/30 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/10/29 12:15 [entrez]
AID - 10.1089/cap.2021.0077 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2021 Nov;31(9):597-609. doi: 
      10.1089/cap.2021.0077. Epub 2021 Oct 29.