PMID- 30575407
OWN - NLM
STAT- MEDLINE
DCOM- 20200317
LR  - 20200317
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 29
IP  - 1
DP  - 2019 Feb
TI  - Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral 
      Suspension in the Treatment of Children with Attention-Deficit/Hyperactivity 
      Disorder.
PG  - 2-8
LID - 10.1089/cap.2018.0078 [doi]
AB  - OBJECTIVE: To determine whether amphetamine extended-release oral suspension 
      (AMPH EROS) has an onset of effect at 30 minutes postdose in children with 
      attention-deficit/hyperactivity disorder (ADHD). METHODS: This randomized, 
      double-blind, two-treatment, two-sequence, placebo-controlled crossover pilot 
      study enrolled subjects aged 6-12 years with ADHD and ADHD-Rating Scale-5 scores 
      of >/=90th percentile for sex and age. An optimized dose of 5-20 mg/day of AMPH 
      EROS was determined during a 1-week open-label dose optimization phase based on 
      medication history, symptom control, and tolerability. Subjects completed a 
      practice laboratory classroom then received 1 day of double-blind active drug or 
      placebo each in random sequence during two double-blind laboratory classroom 
      days. Subjects completed the first double-blind laboratory classroom, returned to 
      open-label drug for 5 days, and then crossed over on day 6 during a second 
      double-blind laboratory classroom. Double-blind dose was fixed at AMPH EROS 15, 
      17.5, or 20 mg. The primary end point was change from predose in the Swanson, 
      Kotkin, Agler, M-Flynn, Pelham-Combined (SKAMP-C) Rating Scale score at 30 
      minutes postdose on two double-blind days. The key secondary end points were 
      change from predose in the SKAMP-C score at 3 hours postdose for AMPH EROS 
      compared with placebo and change from baseline Permanent Product Measure of 
      Performance (PERMP) scores at 30 minutes and 3 hours postdose compared with 
      placebo. Safety assessments included vital signs and adverse events (AEs). 
      RESULTS: Eighteen subjects were enrolled in the study (14 males and 4 females) 
      with a mean age of 9 years. At both 30 minutes and 3 hours postdose, changes from 
      baseline in SKAMP-C for AMPH EROS versus placebo were statistically significant 
      (p < 0.01 and p = 0.0002, respectively). PERMP scores were not statistically 
      significantly improved at 30 minutes postdose for AMPH EROS relative to the 
      placebo group. PERMP scores were statistically significantly improved at 3 hours 
      postdose for AMPH EROS relative to the placebo group (PERMP problems attempted 
      treatment difference least-squares [LS] mean [SE] = 60.3 [12.93], p = 0.0003; 
      PERMP problems correct treatment difference LS mean [SE] = 61.6 [13.16], 
      p = 0.0003). AEs (>10%) during the open-label phase included upper respiratory 
      tract infection, fatigue, upper abdominal pain, headache, decreased appetite, and 
      affect lability. CONCLUSIONS: AMPH EROS was effective in reducing ADHD symptoms 
      at 30 minutes postdose as indicated by SKAMP-C score improvement, although 
      improvements in PERMP scores at 30 minutes were not statistically significant. 
      AEs were mild or moderate and consistent with those of other extended-release 
      amphetamines.
FAU - Childress, Ann C
AU  - Childress AC
AD  - 1 Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada.
FAU - Kando, Judith C
AU  - Kando JC
AD  - 2 Tris Pharma, Inc., Monmouth Junction, New Jersey.
FAU - King, Thomas R
AU  - King TR
AD  - 2 Tris Pharma, Inc., Monmouth Junction, New Jersey.
FAU - Pardo, Antonio
AU  - Pardo A
AD  - 2 Tris Pharma, Inc., Monmouth Junction, New Jersey.
FAU - Herman, Barry K
AU  - Herman BK
AD  - 2 Tris Pharma, Inc., Monmouth Junction, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT03088267
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181221
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Suspensions)
RN  - CK833KGX7E (Amphetamine)
SB  - IM
MH  - Amphetamine/administration & dosage/*therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Central Nervous System Stimulants/administration & dosage/*therapeutic use
MH  - Child
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Pilot Projects
MH  - Psychiatric Status Rating Scales/statistics & numerical data
MH  - Suspensions
MH  - Time Factors
PMC - PMC6362322
OTO - NOTNLM
OT  - ADHD
OT  - amphetamines
OT  - attention-deficit/hyperactivity disorder
OT  - early onset
OT  - efficacy
OT  - extended-release oral suspension
EDAT- 2018/12/24 06:00
MHDA- 2020/03/18 06:00
PMCR- 2019/01/28
CRDT- 2018/12/22 06:00
PHST- 2018/12/24 06:00 [pubmed]
PHST- 2020/03/18 06:00 [medline]
PHST- 2018/12/22 06:00 [entrez]
PHST- 2019/01/28 00:00 [pmc-release]
AID - 10.1089/cap.2018.0078 [pii]
AID - 10.1089/cap.2018.0078 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2019 Feb;29(1):2-8. doi: 10.1089/cap.2018.0078. 
      Epub 2018 Dec 21.