Pharmacotherapy of Attention Deficit Hyperactivity Disorder in Children: Results of a Multicenter, Double-Blind, Placebo-Controlled Trial of Hopantenic Acid

Objectives. To assess the efficacy and safety of hopantenic acid (Pantogam) compared with placebo in the treatment of ADHD for four months in children aged 6–12 years during a prospective, multicenter, comparative, double-blind, placebo-controlled, parallel-group trial. Materials and methods. The study included 100 patients constituting the safety population (50 in the Pantogam group and 50 in the placebo group). A total of 89 patients completing the study in compliance with the protocol entered the efficacy evaluation population: 45 in the Pantogam group (group 1) and 44 in the placebo group (group 2). Pantogam was given as tablets containing 250 mg at the pediatric therapeutic dose of 30 mg/kg, divided into two split doses, for four months. Assessment of patients' statements at follow-up addressed the total points scores on the DSM-IV ADHD, the CGI-S Clinical Global Impression scale, the WFIRS-P functional impairments scale, and the results of a correction test (the Toulouse–Pieron test). Results and conclusions. The efficacy of Pantogam in ADHD in children aged 6–12 years as compared with placebo showed a marked tendency to an increase in the proportion of patients with improvements (decreases in total points scores on the DSM-IV ADHD scale by more than 25%) by the ends of the third and fourth months of treatment: treatment responses were achieved in 66.7% and 68.9%, respectively, compared with 52.3% and 61.4% in the placebo group. Pantogam therapy also produced a decrease in disease severity from the placebo level on the CGI-S scale. At four months of Pantogam treatment, there were decreases in the severity of functional impairments on sections 4 and 6 of the WFIRES-P "Family," "School and learning," "Child's self-concept," and "Risky activities" scales. Pantogam also improved the maintenance of attention in children with ADHD, as measured using the Toulouse–Pieron test (quality and rate of performance) as compared with placebo. Treatment with Pantogam at a mean daily dose of 30 mg/kg for four months demonstrated a favorable safety profile, no different from that of placebo.

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