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(1): 73-84.e1, 2011 Jan.
Article
en En
| MEDLINE
| ID: mdl-21156272
ABSTRACT
OBJECTIVE:
To assess the safety and efficacy of ABT-089, a novel α(4)ß(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.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Piridinas
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Pirrolidinas
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Trastorno por Déficit de Atención con Hiperactividad
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
Límite:
Adult
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Child
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Female
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Humans
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Male
Idioma:
En
Revista:
J Am Acad Child Adolesc Psychiatry
Asunto de la revista:
PEDIATRIA
/
PSIQUIATRIA
Año:
2011
Tipo del documento:
Article
País de afiliación:
Estados Unidos