Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

Summary

The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.

Timeline

Start

2008-11-17

Primary completion

2011-03-16

Completion

2011-03-16

Outcome

Met primary endpoint

registry analysis (unspecified test); Lisdexamfetamine Dimesylate (LDX) vs Placebo; p <0.001; difference in LS means -18.6 (95% CI -21.5 to -15.7); ANCOVA NCT00763971 ↗

paper The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -18.6 (95% confidence interval [CI]: -21.5 to -15.7) (p<0.001; effect size, 1.80). PMID 23332456 ↗

Publications

• Results Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15.
• Results Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25.
• Results Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5.
• Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lisdexamfetamine	Other / unclassified	30 mg	Oral
Subject	Lisdexamfetamine	Other / unclassified	50 mg	Oral
Subject	Lisdexamfetamine	Other / unclassified	70 mg	Oral
Comparator	Methylphenidate	Small molecule	18 mg	Oral
Comparator	Methylphenidate	Small molecule	36 mg	Oral
Comparator	Methylphenidate	Small molecule	54 mg	Oral

Indications