32 Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder Article Swipe
Ann Childress
,
Antonio Pardo
,
Thomas King
,
Judith C. Kando
,
Barry K. Herman
·
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1017/s1092852919000269
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1017/s1092852919000269
Objective To determine whether amphetamine extended-release oralsuspension (AMPH EROS) has an onset of effect at 30minutes postdose inchildren with ADHD. Methods This randomized, double-blind, 2-treatment, 2-sequence, placebo-controlled crossover pilot study enrolled subjects aged 6 to 12 years withattention-deficit/hyperactivity disorder (ADHD) and ADHD-Rating Scale-5 scores of ≥90th percentile for sex and age. A dose of 5 to 20mg/day of AMPH EROS was determined during a 1-week open-label phase based on medication history, symptom control, and tolerability. Subjects completed a practice laboratory classroom then received one day of double-blind active drug or placebo each in random sequence during 2 double-blind laboratory classroom days. Subjects completed the first double-blind laboratory classroom session, returned to open label drug for 5days then crossed over on day 6 during a second double-blind laboratory classroom session. DB dose was fixed at AMPH EROS 15, 17.5, or 20mg . The primary endpoint was change from predose in the Swanson, Kotkin, Agler, M-Flynn, Pelham rating scale-combined score (SKAMP-C) at 30minutes postdose on two DB days. The key secondary endpoint was change from predose in the SKAMP-C score at 3hours postdose for AMPH EROS compared with placebo. Safety assessments included vital signs and adverse events. Results Eighteen subjects were enrolled in the study (14 males and 4 females) with a mean age of 9 years. At both 30minutes and 3hours postdose, changes from baseline in SKAMP-C for AMPH EROS vs. placebo were statistically significant (p<0.01 and p=0.0002, respectively) with corresponding effect sizes of 0.96 and 1.57. Adverse events (>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 30minutes postdose. AEs were mild or moderate and consistent with those of other extended-release amphetamines. Funding Acknowledgements: Support was provided by Tris Pharma, Inc.
Related Topics
Concepts
Tolerability
Placebo
Medicine
Attention deficit hyperactivity disorder
Adverse effect
Clinical endpoint
Amphetamine
Rating scale
Crossover study
Randomized controlled trial
Clinical trial
Pediatrics
Anesthesia
Psychology
Psychiatry
Internal medicine
Developmental psychology
Alternative medicine
Pathology
Dopamine
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1017/s1092852919000269
- https://www.cambridge.org/core/services/aop-cambridge-core/content/view/6EA747C6DCD699D6134C88955B995815/S1092852919000269a.pdf/div-class-title-32-early-onset-efficacy-and-safety-pilot-study-of-amphetamine-extended-release-oral-suspension-amph-eros-in-the-treatment-of-children-with-attention-deficit-hyperactivity-disorder-div.pdf
- OA Status
- bronze
- Cited By
- 2
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2921993194
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2921993194Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1017/s1092852919000269Digital Object Identifier
- Title
-
32 Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in the Treatment of Children with Attention-Deficit/Hyperactivity DisorderWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2019Year of publication
- Publication date
-
2019-02-01Full publication date if available
- Authors
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Ann Childress, Antonio Pardo, Thomas King, Judith C. Kando, Barry K. HermanList of authors in order
- Landing page
-
https://doi.org/10.1017/s1092852919000269Publisher landing page
- PDF URL
-
https://www.cambridge.org/core/services/aop-cambridge-core/content/view/6EA747C6DCD699D6134C88955B995815/S1092852919000269a.pdf/div-class-title-32-early-onset-efficacy-and-safety-pilot-study-of-amphetamine-extended-release-oral-suspension-amph-eros-in-the-treatment-of-children-with-attention-deficit-hyperactivity-disorder-div.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
-
https://www.cambridge.org/core/services/aop-cambridge-core/content/view/6EA747C6DCD699D6134C88955B995815/S1092852919000269a.pdf/div-class-title-32-early-onset-efficacy-and-safety-pilot-study-of-amphetamine-extended-release-oral-suspension-amph-eros-in-the-treatment-of-children-with-attention-deficit-hyperactivity-disorder-div.pdfDirect OA link when available
- Concepts
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Tolerability, Placebo, Medicine, Attention deficit hyperactivity disorder, Adverse effect, Clinical endpoint, Amphetamine, Rating scale, Crossover study, Randomized controlled trial, Clinical trial, Pediatrics, Anesthesia, Psychology, Psychiatry, Internal medicine, Developmental psychology, Alternative medicine, Pathology, DopamineTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
2Total citation count in OpenAlex
- Citations by year (recent)
-
2023: 1, 2022: 1Per-year citation counts (last 5 years)
- Related works (count)
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10Other works algorithmically related by OpenAlex
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