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Efficacy and safety of the novel α₄β₂ neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study.

AbstractRATIONALE:
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 (2 mg once daily [QD], 5 mg QD, 15 mg QD, 40 mg QD, or 40 mg twice daily [BID]), or vice versa, in a 2 × 2 crossover design. Each treatment period was 4 weeks, 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 40 mg QD and 40 mg 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 phase 2 crossover study, the NNR partial agonist ABT-089, at doses of 40 mg QD and 40 mg BID, was efficacious and generally well tolerated in treatment of adults with ADHD.
AuthorsGeorge Apostol, Walid Abi-Saab, Christopher J Kratochvil, Lenard A Adler, Weining Z Robieson, Laura M Gault, Yili L Pritchett, David Feifel, Michelle A Collins, Mario D Saltarelli
JournalPsychopharmacology (Psychopharmacology (Berl)) Vol. 219 Issue 3 Pg. 715-25 (Feb 2012) ISSN: 1432-2072 [Electronic] Germany
PMID21748252 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Nicotinic Agonists
  • Pyridines
  • Pyrrolidines
  • Receptors, Nicotinic
  • nicotinic receptor alpha4beta2
  • pozanicline
Topics
  • Adult
  • Attention Deficit Disorder with Hyperactivity (drug therapy, psychology)
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Partial Agonism
  • Female
  • Headache (chemically induced)
  • Humans
  • Irritable Mood (drug effects)
  • Male
  • Middle Aged
  • Nicotinic Agonists (therapeutic use)
  • Pyridines (adverse effects, therapeutic use)
  • Pyrrolidines (adverse effects, therapeutic use)
  • Receptors, Nicotinic (physiology)
  • Treatment Outcome

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