Abstract | RATIONALE: 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.
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Authors | George 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 |
Journal | Psychopharmacology
(Psychopharmacology (Berl))
Vol. 219
Issue 3
Pg. 715-25
(Feb 2012)
ISSN: 1432-2072 [Electronic] Germany |
PMID | 21748252
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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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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