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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by University of Oklahoma.
Recruitment status was:  Recruiting
Mark L. Wolraich
Eli Lilly and Company
Information provided by:
University of Oklahoma Identifier:
First received: January 2, 2007
Last updated: December 6, 2010
Last verified: December 2010
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Condition Intervention Phase
Fetal Alcohol Syndrome Attention Deficit Disorder (ADD) Attention Deficit Disorder With Hyperactivity (ADHD) Drug: atomoxetine hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Determine if atomoxetine is safe and well tolerated by children with FASD. [ Time Frame: 12 months or study duration ]

Secondary Outcome Measures:
  • Determine if there are any differences in the adverse effects profile of children with FASD compared to the overall profile for atomoxetine. [ Time Frame: 12 months or study duration ]
  • Determine if changes in behavior seen with short-term (eight weeks) treatment of children are maintained over a twelve month period. [ Time Frame: 12 months or study duration ]
  • Compare growth while on atomoxetine with growth before entry into study. [ Time Frame: 12 months or study duration ]

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atomoxetine HCL (Strattera)
Drug: atomoxetine hydrochloride
0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.

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.

Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must have been between the ages of 4 and 11 years at the time of entry into the double blind study.
  • Patients must meet diagnostic criteria for FASD.
  • Patient must, at entry into doubleblind study, have met DSM-IV criteria for ADHD, any subtype. And must have an ADHDRS-IV score of > or + 90% for age and gender on either subtest or total score for children above 5 years of age.
  • Patients will continue atomoxetine/placebo until entry nto this study.
  • History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study.
  • Patients must be able to swallow capsules.
  • Patients must be of a sufficient mental age (3 yrs) to participate in the study.
  • Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection.
  • Teacher must agree to cooperate with the study.

Exclusion Criteria:

  • Have received an investigational medication other than atomoxetine in the previous 30 days.
  • Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
  • Have used MAOIs within one month prior to visit 1.
  • Patients with hypertension.
  • Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder.
  • Patients taking anticonvulsants for seizure control.
  • Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 1.
  • Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring.
  • Pubertal girls.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00418262

Contact: Lora D Tusing, BS, RN 405-271-5700 ext 45167
Contact: Brenda Schlinke, RN 405-271-5700 ext 45167

United States, Oklahoma
OU Child Study Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Lora D Tusing, BS, RN    405-271-5700 ext 45167   
Contact: Brenda Schlinke, RN    405-271-5700 ext 45167   
Principal Investigator: Thomas M Lock, M.D.         
Sub-Investigator: Mark L Wolraich, M.D.         
Sub-Investigator: Laura J McGuinn, M.D.         
Sponsors and Collaborators
University of Oklahoma
Mark L. Wolraich
Eli Lilly and Company
Principal Investigator: Thomas M Lock, M.D. University of Oklahoma
  More Information

Responsible Party: Thomas M. Lock, M.D., OU Child Study Center Identifier: NCT00418262     History of Changes
Other Study ID Numbers: B4Z-MC-X050
Study First Received: January 2, 2007
Last Updated: December 6, 2010

Keywords provided by University of Oklahoma:
fetal alcohol syndrome
attention deficit disorder
attention deficit disorder with hyperactivity

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Fetal Alcohol Spectrum Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on June 26, 2017