PMID- 29211967
OWN - NLM
STAT- MEDLINE
DCOM- 20191003
LR  - 20191007
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 28
IP  - 5
DP  - 2018 Jun
TI  - Efficacy and Safety of Amphetamine Extended-Release Oral Suspension in Children 
      with Attention-Deficit/Hyperactivity Disorder.
PG  - 306-313
LID - 10.1089/cap.2017.0095 [doi]
AB  - OBJECTIVES: To determine the efficacy and safety of amphetamine extended-release 
      oral suspension (AMPH EROS) in the treatment of attention-deficit/hyperactivity 
      disorder (ADHD) in a dose-optimized, randomized, double-blind, parallel-group 
      study. METHODS: Boys and girls aged 6 to 12 years diagnosed with ADHD were 
      enrolled. During a 5-week, open-label, dose-optimization phase, patients began 
      treatment with 2.5 or 5 mg/day of AMPH EROS; doses were titrated until an optimal 
      dose (maximum 20 mg/day) was reached. During the double-blind phase, patients 
      were randomized to receive treatment with either their optimized dose 
      (10-20 mg/day) of AMPH EROS or placebo for 1 week. Efficacy was assessed in a 
      laboratory classroom setting on the final day of double-blind treatment using the 
      Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent 
      Product Measure of Performance (PERMP) test. Safety was assessed measuring 
      adverse events (AEs) and vital signs. RESULTS: The study was completed by 99 
      patients. The primary efficacy endpoint (change from predose SKAMP-Combined score 
      at 4 hours postdose) and secondary endpoints (change from predose SKAMP-Combined 
      scores at 1, 2, 6, 8, 10, 12, and 13 hours postdose) were statistically 
      significantly improved with AMPH EROS treatment versus placebo at all time 
      points. Onset of treatment effect was present by 1 hour postdosing, the first 
      time point measured, and duration of efficacy lasted 13 hours postdosing. PERMP 
      data mirrored the SKAMP-Combined score data. AEs (>5%) reported during dose 
      optimization were decreased appetite, insomnia, affect lability, upper abdominal 
      pain, mood swings, and headache. CONCLUSION: AMPH EROS was effective in reducing 
      symptoms of ADHD and had a rapid onset and extended duration of effect. Reported 
      AEs were consistent with those of other extended-release amphetamine products.
FAU - Childress, Ann C
AU  - Childress AC
AD  - 1 Center for Psychiatry and Behavioral Medicine, Inc. , Las Vegas, Nevada.
FAU - Wigal, Sharon B
AU  - Wigal SB
AD  - 2 AVIDA, Inc. , Newport Beach, California.
FAU - Brams, Matthew N
AU  - Brams MN
AD  - 3 Bayou City Research, Ltd. , Houston, Texas.
FAU - Turnbow, John M
AU  - Turnbow JM
AD  - 4 Westex Clinical Investigations , Lubbock, Texas.
FAU - Pincus, Yulia
AU  - Pincus Y
AD  - 5 Tris Pharma, Inc. , Monmouth Junction, New Jersey.
FAU - Belden, Heidi W
AU  - Belden HW
AD  - 5 Tris Pharma, Inc. , Monmouth Junction, New Jersey.
FAU - Berry, Sally A
AU  - Berry SA
AD  - 5 Tris Pharma, Inc. , Monmouth Junction, New Jersey.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171206
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 (Delayed-Action Preparations)
RN  - 0 (Suspensions)
RN  - CK833KGX7E (Amphetamine)
SB  - IM
MH  - Amphetamine/*therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Central Nervous System Stimulants/*therapeutic use
MH  - Child
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Suspensions
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC5994670
OTO - NOTNLM
OT  - amphetamine
OT  - attention-deficit/hyperactivity disorder
OT  - extended-release
OT  - laboratory school
OT  - liquid formulation
OT  - oral suspension
EDAT- 2017/12/07 06:00
MHDA- 2019/10/08 06:00
PMCR- 2018/06/01
CRDT- 2017/12/07 06:00
PHST- 2017/12/07 06:00 [pubmed]
PHST- 2019/10/08 06:00 [medline]
PHST- 2017/12/07 06:00 [entrez]
PHST- 2018/06/01 00:00 [pmc-release]
AID - 10.1089/cap.2017.0095 [pii]
AID - 10.1089/cap.2017.0095 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2018 Jun;28(5):306-313. doi: 
      10.1089/cap.2017.0095. Epub 2017 Dec 6.