At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 27 enrolled
Drug / intervention
Atomoxetinedrug
Likely dose
Atomoxetine 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Atomoxetine for Fetal Alcohol Syndrome and Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 27 participants across 1 site.
Detailed Summary
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMark L. Wolraich
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2005
First PostedJan 2007
Primary CompletionApr 2015
TodayJul 2026
First PostedJan 4, 2007
Enrollment StartAug 1, 2005
Primary CompletionApr 22, 2015
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 19.5 years ago
Interventions
Atomoxetinedrug
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.