Wilens_2011_J.Am.Acad.Child.Adolesc.Psychiatry_50_73

Reference

Title : Safety and efficacy of ABT-089 in pediatric attention-deficit\/hyperactivity disorder: results from two randomized placebo-controlled clinical trials - Wilens_2011_J.Am.Acad.Child.Adolesc.Psychiatry_50_73
Author(s) : Wilens TE , Gault LM , Childress A , Kratochvil CJ , Bensman L , Hall CM , Olson E , Robieson WZ , Garimella TS , Abi-Saab WM , Apostol G , Saltarelli MD
Ref : J Am Acad Child Adolesc Psychiatry , 50 :73 , 2011
Abstract :

OBJECTIVE: To assess the safety and efficacy of ABT-089, a novel alpha(4)beta(2) neuronal nicotinic receptor partial agonist, vs. placebo in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: Two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of children 6 through 12 years of age were conducted. Study 1 (n = 274) assessed six treatment groups over 8 weeks: 4 once-daily (QD) ABT-089 doses (0.085-0.700 mg/kg), QD atomoxetine, and placebo. Study 2 (n = 119) assessed three treatment groups over 6 weeks: 2 QD ABT-089 doses (0.7 mg/kg, 1.4 mg/kg) and placebo. The primary efficacy variable was the investigator-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV: Home Version (ADHD-RS-IV [HV]) Total Score. Safety was assessed by adverse event (AE) monitoring, laboratory tests, vital signs, physical examinations, and electrocardiogram measures.
RESULTS: There was no statistically significant difference between ABT-089 and placebo in mean change from baseline to final evaluation of ADHD-RS-IV (HV) Total Score or other outcome measures at any dose in either study. In Study 1, atomoxetine showed statistically significant improvement for the primary and most secondary endpoints. ABT-089 was generally safe and well tolerated, with no statistically significant difference between any ABT-089 dose and placebo in the overall incidence of any specific AE, and no clinically significant changes in other safety measures.
CONCLUSIONS: ABT-089 did not show efficacy on the primary efficacy variable, the ADHD-RS-IV (HV) Total Score, or other measures of ADHD symptomatology in children with ADHD, and had a safety profile similar to placebo. These results contrast with published reports of efficacy of nicotinic modulators in adults with ADHD.

PubMedSearch : Wilens_2011_J.Am.Acad.Child.Adolesc.Psychiatry_50_73
PubMedID: 21156272

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Citations formats

Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD (2011)
Safety and efficacy of ABT-089 in pediatric attention-deficit\/hyperactivity disorder: results from two randomized placebo-controlled clinical trials
J Am Acad Child Adolesc Psychiatry 50 :73

Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD (2011)
J Am Acad Child Adolesc Psychiatry 50 :73