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The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study.

Childress AC, Brams M, Cutler AJ, Kollins SH, Northcutt J, Padilla A, Turnbow JM - J Child Adolesc Psychopharmacol (2015)

Bottom Line: Compared to placebo, a single daily dose of R-AMPH significantly improved SKAMP-Combined scores (p<0.0001) at each time point tested throughout the laboratory classroom days, with effect onset 45 minutes postdose and extending through 10 hours.R-AMPH significantly improved PERMP number of problems attempted and correct (p<0.0001) throughout the laboratory classroom days.TEAEs and changes in vital signs associated with R-AMPH were generally mild and not unexpected.

View Article: PubMed Central - PubMed

Affiliation: 1 Center for Psychiatry and Behavioral Medicine , Las Vegas, Nevada.

ABSTRACT

Objective: The study goal was to determine the efficacy and safety of an optimal dose of Evekeo, racemic amphetamine sulfate, 1:1 d-amphetamine and l-amphetamine (R-AMPH), compared to placebo in treating children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting.

Methods: A total of 107 children ages 6-12 years were enrolled in this multicenter, dose-optimized, randomized, double-blind, placebo-controlled crossover study. After 8 weeks of open-label dose optimization, 97 subjects were randomized to 2 weeks of double-blind treatment in the sequence of R-AMPH followed by placebo (n=47) or placebo followed by R-AMPH (n=50). Efficacy measures included the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP) administered predose and at 0.75, 2, 4, 6, 8, and 10 hours postdose on 2 laboratory classroom days. Safety assessments included physical examination, chemistry, hematology, vital signs, and treatment-emergent adverse events (TEAEs).

Results: Compared to placebo, a single daily dose of R-AMPH significantly improved SKAMP-Combined scores (p<0.0001) at each time point tested throughout the laboratory classroom days, with effect onset 45 minutes postdose and extending through 10 hours. R-AMPH significantly improved PERMP number of problems attempted and correct (p<0.0001) throughout the laboratory classroom days. During the twice-daily dose-optimization open-label phase, improvements were observed with R-AMPH in scores of the ADHD-Rating Scale IV and Clinical Global Impressions Severity and Improvement Scales. TEAEs and changes in vital signs associated with R-AMPH were generally mild and not unexpected. The most common TEAEs in the open-label phase were decreased appetite (27.6%), upper abdominal pain (14.3%), irritability (14.3%), and headache (13.3%).

Conclusions: Compared to placebo, R-AMPH was effective in treating children aged 6-12 years with ADHD, beginning at 45 minutes and continuing through 10 hours postdose, and was well tolerated.

Trial registration: ClinicalTrials.gov identifier: NCT01986062. https://clinicaltrials.gov/ct2/show/NCT01986062.

No MeSH data available.


Related in: MedlinePlus

Subject disposition in the R-AMPH laboratory classroom study.
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f2: Subject disposition in the R-AMPH laboratory classroom study.

Mentions: Subject disposition is summarized in Figure 2. Of 107 subjects enrolled in the 8-week open-label phase of the study, 10 withdrew before randomization, leaving 97 subjects for the ITT population and for the randomized safety population—47 subjects randomized to the treatment sequence of R-AMPH followed by placebo and 50 to the sequence of placebo followed by R-AMPH. Two randomized subjects completed only one of the two double-blind period laboratory classroom days—one subject was unable to come for the second laboratory classroom day, and one was lost to follow-up. Therefore, the clinically evaluable population for repeat analyses of the primary and secondary efficacy variables consisted of 95 subjects (97.94%) from the ITT population. The enrolled safety population for analyzing safety data across the entire study consisted of 105 of the 107 total enrolled subjects. One subject not included withdrew prematurely due to an AE (irritability) after receiving the study drug but before having any postbaseline safety assessments; the other subject was discontinued at the discretion of the investigator, also without having any postbaseline safety assessments.


The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study.

Childress AC, Brams M, Cutler AJ, Kollins SH, Northcutt J, Padilla A, Turnbow JM - J Child Adolesc Psychopharmacol (2015)

Subject disposition in the R-AMPH laboratory classroom study.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4491157&req=5

f2: Subject disposition in the R-AMPH laboratory classroom study.
Mentions: Subject disposition is summarized in Figure 2. Of 107 subjects enrolled in the 8-week open-label phase of the study, 10 withdrew before randomization, leaving 97 subjects for the ITT population and for the randomized safety population—47 subjects randomized to the treatment sequence of R-AMPH followed by placebo and 50 to the sequence of placebo followed by R-AMPH. Two randomized subjects completed only one of the two double-blind period laboratory classroom days—one subject was unable to come for the second laboratory classroom day, and one was lost to follow-up. Therefore, the clinically evaluable population for repeat analyses of the primary and secondary efficacy variables consisted of 95 subjects (97.94%) from the ITT population. The enrolled safety population for analyzing safety data across the entire study consisted of 105 of the 107 total enrolled subjects. One subject not included withdrew prematurely due to an AE (irritability) after receiving the study drug but before having any postbaseline safety assessments; the other subject was discontinued at the discretion of the investigator, also without having any postbaseline safety assessments.

Bottom Line: Compared to placebo, a single daily dose of R-AMPH significantly improved SKAMP-Combined scores (p<0.0001) at each time point tested throughout the laboratory classroom days, with effect onset 45 minutes postdose and extending through 10 hours.R-AMPH significantly improved PERMP number of problems attempted and correct (p<0.0001) throughout the laboratory classroom days.TEAEs and changes in vital signs associated with R-AMPH were generally mild and not unexpected.

View Article: PubMed Central - PubMed

Affiliation: 1 Center for Psychiatry and Behavioral Medicine , Las Vegas, Nevada.

ABSTRACT

Objective: The study goal was to determine the efficacy and safety of an optimal dose of Evekeo, racemic amphetamine sulfate, 1:1 d-amphetamine and l-amphetamine (R-AMPH), compared to placebo in treating children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting.

Methods: A total of 107 children ages 6-12 years were enrolled in this multicenter, dose-optimized, randomized, double-blind, placebo-controlled crossover study. After 8 weeks of open-label dose optimization, 97 subjects were randomized to 2 weeks of double-blind treatment in the sequence of R-AMPH followed by placebo (n=47) or placebo followed by R-AMPH (n=50). Efficacy measures included the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP) administered predose and at 0.75, 2, 4, 6, 8, and 10 hours postdose on 2 laboratory classroom days. Safety assessments included physical examination, chemistry, hematology, vital signs, and treatment-emergent adverse events (TEAEs).

Results: Compared to placebo, a single daily dose of R-AMPH significantly improved SKAMP-Combined scores (p<0.0001) at each time point tested throughout the laboratory classroom days, with effect onset 45 minutes postdose and extending through 10 hours. R-AMPH significantly improved PERMP number of problems attempted and correct (p<0.0001) throughout the laboratory classroom days. During the twice-daily dose-optimization open-label phase, improvements were observed with R-AMPH in scores of the ADHD-Rating Scale IV and Clinical Global Impressions Severity and Improvement Scales. TEAEs and changes in vital signs associated with R-AMPH were generally mild and not unexpected. The most common TEAEs in the open-label phase were decreased appetite (27.6%), upper abdominal pain (14.3%), irritability (14.3%), and headache (13.3%).

Conclusions: Compared to placebo, R-AMPH was effective in treating children aged 6-12 years with ADHD, beginning at 45 minutes and continuing through 10 hours postdose, and was well tolerated.

Trial registration: ClinicalTrials.gov identifier: NCT01986062. https://clinicaltrials.gov/ct2/show/NCT01986062.

No MeSH data available.


Related in: MedlinePlus