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

NCT00418262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-07-02

Study results available
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Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Mark L. Wolraich

    collaborator UNKNOWN

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Laura J McGuinn, M.D. · University of Oklahoma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2015-04-22
Completion
2015-04-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00418262 on ClinicalTrials.gov