A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder

Phase 2/3 Completed 340 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it.

Timeline

Start: 2009-06
Primary completion: 2010-12
Completion: 2010-12

Outcome

Met primary endpoint

paper The edivoxetine 0.2 mg/kg/day and 0.3 mg/kg/day arms had statistically significantly greater improvement than the placebo arm PMID 24840045 ↗

registry Placebo vs LY2216684 (0.2 mg/kg/Day); p = 0.008; Mean Difference (Final Values) -5.74 NCT00922636 ↗

registry Placebo vs LY2216684 (0.3 mg/kg/Day); p = 0.006; Mean Difference (Final Values) -6.04 NCT00922636 ↗

Publications

Lin DY, Kratochvil CJ, Xu W, Jin L, D'Souza DN, Kielbasa W, Allen AJ. A randomized trial of edivoxetine in pediatric patients with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):190-200. doi: 10.1089/cap.2013.0043.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Methylphenidate	Small molecule	18 mg	Oral
Comparator	Methylphenidate	Small molecule	54 mg	Oral
Subject	edivoxetine	Small molecule	0.1 mg/kg	Oral
Subject	edivoxetine	Small molecule	0.2 mg/kg	Oral
Subject	edivoxetine	Small molecule	0.3 mg/kg	Oral