NCT00418262

Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD

An Open-label Study of the Long Term Tolerability and Safety of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal-Alcohol Syndrome or Effects.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Detailed description

Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity (ADHD) symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.

Conditions

• Fetal Alcohol Syndrome
• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	Atomoxetine	Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.

Timeline

• Start date: 2005-08-01
• Primary completion: 2015-04-22
• Completion: 2015-04-22
• First posted: 2007-01-04
• Last updated: 2017-07-02
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States