Abstract

This revised application proposes a pilot multicenter randomized placebo-controlled clinical trial of levodopa in children with ADHD both with and without periodic limb movements of sleep (PLMS) and restless legs syndrome (RLS). Both of these conditions may involve abnormalities of dopaminergic neurotransmission, and the proposal presents evidence that children with ADHD have a high rate of PLMS/RLS. PLMS/RLS is known to respond to dopaminergic medications, including levodopa, but there is only anecdotal evidence that these medications help ADHD. ADHD is a common childhood problem for which alternative medications to stimulants are needed. Although this trial may not be powered to detect small differences between groups, the goal is to look for trends to assess whether a large multicenter trial is warranted.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS040829-02
Application #
6669157
Study Section
Special Emphasis Panel (ZNS1-SRB-K (01))
Program Officer
Leblanc, Gabrielle G
Project Start
2002-09-30
Project End
2005-07-31
Budget Start
2003-08-01
Budget End
2004-07-31
Support Year
2
Fiscal Year
2003
Total Cost
$413,866
Indirect Cost

  Institution

Name
JFK Medical Center
Department
Type
DUNS #
068678721
City
Edison
State
NJ
Country
United States
Zip Code
08820

  Publications

Ferri, Raffaele; Bruni, Oliviero; Novelli, Luana et al. (2013) Time structure of leg movement activity during sleep in attention-deficit/hyperactivity disorder and effects of levodopa. Sleep Med 14:359-66
England, Sandra J; Picchietti, Daniel L; Couvadelli, Barbara Vera et al. (2011) L-Dopa improves Restless Legs Syndrome and periodic limb movements in sleep but not Attention-Deficit-Hyperactivity Disorder in a double-blind trial in children. Sleep Med 12:471-7
Picchietti, Matthew A; Picchietti, Daniel L (2010) Advances in pediatric restless legs syndrome: Iron, genetics, diagnosis and treatment. Sleep Med 11:643-51
Picchietti, Matthew A; Picchietti, Daniel L; England, Sandra J et al. (2009) Children show individual night-to-night variability of periodic limb movements in sleep. Sleep 32:530-5
Picchietti, Daniel L; Rajendran, Ramji R; Wilson, Michael P et al. (2009) Pediatric restless legs syndrome and periodic limb movement disorder: parent-child pairs. Sleep Med 10:925-31
Picchietti, Daniel L; Stevens, Hanna E (2008) Early manifestations of restless legs syndrome in childhood and adolescence. Sleep Med 9:770-81