Efficacy and safety of the novel αβ neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study.

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作者：

G Apostol，W Abi-Saab，CJ Kratochvil，LA Adler，WZ Robieson，LM Gault，YL Pritchett，D Feifel，MA Collins，MD Saltarelli

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摘要：

Rationale α 4 β 2 Neuronal nicotinic receptors (NNRs) are implicated in the pathophysiology of attention-deficit/hyperactivity disorder ( ADHD ). Objectives This study examined the efficacy and safety of the α 4 β 2 NNR partial agonist ABT-089 versus placebo in adults with ADHD . Methods In this multicenter, randomized, double-blind, placebo-controlled crossover study, subjects received placebo followed by ABT-089 (2mg once daily [QD], 5mg QD, 15mg QD, 40mg QD, or 40mg twice daily [BID]), or vice versa, in a 2×2 crossover design. Each treatment period was 4weeks, separated by a 2-week washout period. The primary efficacy endpoint was the Conners' Adult ADHD Rating Scale–Investigator Rated (CAARS:Inv) total score at the end of each treatment period. Secondary outcomes based on clinician- and self-rated efficacy scales were evaluated. Results Of the 221 subjects enrolled, 171 met criteria for inclusion in the completers dataset for efficacy analyses. ABT-089 was superior to placebo on the CAARS:Inv total score at 40mg QD and 40mg BID (model-based least square mean difference from placebo: 4.33, P =0.02; 3.02, P =0.03, respectively). ABT-089 also demonstrated significant improvements on several secondary measures of efficacy. ABT-089 was generally safe and well tolerated. The most commonly reported adverse events (≥5%) for total ABT-089-treated subjects at rates higher than placebo were headache, upper respiratory tract infection, irritability, insomnia, and nasopharyngitis. Conclusions In this phase2 crossover study, the NNR partial agonist ABT-089, at doses of 40mg QD and 40mg BID, was efficacious and generally well tolerated in treatment of adults with ADHD .

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关键词：

Nicotinic ADHD Attention

DOI：

10.1007/s00213-011-2393-2

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年份：

2012