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.”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Atomoxetine HCL (Strattera)

Primary Measures

• Determine if atomoxetine is safe and well tolerated by children with FASD.
  • Time Frame: 12 months or study duration
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes
• 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
    Safety Issue?: No
• Compare growth while on atomoxetine with growth before entry into study.
  • Time Frame: 12 months or study duration
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Oklahoma

Overall Clinical Trial Officials and Contacts

Thomas M Lock, M.D. Principal Investigator University of Oklahoma  

Overall Contact: Lora D Tusing, B.S. 405-271-5700 lora-tusing@ouhsc.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00418262

Study ID Number: B4Z-MC-X050

ClinicalTrials.gov Identifier: NCT00418262

Health Authority: United States: Institutional Review Board