Study Supports Safety, Efficacy of Racemic Amphetamine Sulfate for Children With ADHD
Juni 29, 2015
NEW ROCHELLE, NY -- June 29, 2015 -- Racemic amphetamine sulfate (Evekeo) given once or twice daily to children aged 6 to 12 years is effective in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and improving performance in a laboratory classroom setting.
The findings are published in the current issue of the Journal of Child and Adolescent Psychopharmacology.
Ann C. Childress, MD, Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada, and colleagues compared the safety and efficacy of a racemic formulation with a ratio of 1:1 D- and L-amphetamine (R-AMPH) versus placebo using rating scales and performance measures designed to assess ADHD symptoms as well as behaviour and productivity in the classroom.
A total of 107 children aged 6 to 12 years were enrolled in the multicentre, dose-optimised, randomized, double-blind, placebo-controlled crossover study. After 8 weeks of open-label dose optimisation, 97 subjects were randomised 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 pre-dose and at 0.75, 2, 4, 6, 8, and 10 hours post dose on 2 laboratory classroom days. Safety assessments included physical examination, chemistry, haematology, vital signs, and treatment-emergent adverse events (TEAEs).
Compared with placebo, a single daily dose of R-AMPH significantly improved SKAMP-combined scores (P < .0001) at each time-point tested throughout the laboratory classroom days, with effect onset 45 minutes post dose and extending through 10 hours.
R-AMPH significantly improved PERMP number of problems attempted and correct (P < .0001) throughout the laboratory classroom days.
During the twice-daily dose-optimisation 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%).
SOURCE: Mary Ann Liebert, Inc.