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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

PERMP number of problems correct over time by treatment group. PERMP, Permanent Product Measure of Performance.
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Related In: Results  -  Collection


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f5: PERMP number of problems correct over time by treatment group. PERMP, Permanent Product Measure of Performance.

Mentions: When subjects received R-AMPH, they attempted more problems on the PERMP and answered more of those questions correctly than when they received placebo. At each time point tested in the laboratory classroom setting (0.75, 2, 4, 6, 8, and 10 hours), both the number of problems attempted (Fig. 4) and the number of problems answered correctly on the PERMP (Fig. 5) were significantly higher (p<0.0001 in all cases) after subjects received R-AMPH. While the greatest R-AMPH effect was seen at 4 hours postdose for the number of problems attempted (difference in LS means of 27.9 problems attempted) and at 2 hours postdose for the number of problems correct (difference in LS means of 28.0 problems correct), similar effect levels were seen between 2 and 6 hours for both categories (range of differences in LS means of 26.3 to 27.9 problems attempted and 24.9 to 28.0 problems correct). When PERMP scores were examined across the different subgroups (final dose, subject age, gender, race, ADHD type) with regard to the number of problems attempted and the number of problems correct, statistically significant differences in LS means favoring R-AMPH treatment over placebo were observed at each time point through 10 hours postdose, with trends similar to those for the ITT population as a whole.


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)

PERMP number of problems correct over time by treatment group. PERMP, Permanent Product Measure of Performance.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

f5: PERMP number of problems correct over time by treatment group. PERMP, Permanent Product Measure of Performance.
Mentions: When subjects received R-AMPH, they attempted more problems on the PERMP and answered more of those questions correctly than when they received placebo. At each time point tested in the laboratory classroom setting (0.75, 2, 4, 6, 8, and 10 hours), both the number of problems attempted (Fig. 4) and the number of problems answered correctly on the PERMP (Fig. 5) were significantly higher (p<0.0001 in all cases) after subjects received R-AMPH. While the greatest R-AMPH effect was seen at 4 hours postdose for the number of problems attempted (difference in LS means of 27.9 problems attempted) and at 2 hours postdose for the number of problems correct (difference in LS means of 28.0 problems correct), similar effect levels were seen between 2 and 6 hours for both categories (range of differences in LS means of 26.3 to 27.9 problems attempted and 24.9 to 28.0 problems correct). When PERMP scores were examined across the different subgroups (final dose, subject age, gender, race, ADHD type) with regard to the number of problems attempted and the number of problems correct, statistically significant differences in LS means favoring R-AMPH treatment over placebo were observed at each time point through 10 hours postdose, with trends similar to those for the ITT population as a whole.

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