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

Fetal Alcohol Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00418262
• Other study ID #: B4Z-MC-X050
• Status: Recruiting
• Phase: Phase 3
• First received: January 2, 2007
• Last updated: December 6, 2010
• Start date: June 2006
• Est. completion date: June 2011

Study information

• Verified date: December 2010
• Source: University of Oklahoma
• Contact: Lora D Tusing, BS, RN
• Phone: 405-271-5700
• Email: lora-tusing[@]ouhsc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder (ADD)
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Disorder With Hyperactivity (ADHD)
• Disease
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
United States	OU Child Study Center	Oklahoma City	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	Eli Lilly and Company, Mark L. Wolraich

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if atomoxetine is safe and well tolerated by children with FASD.		12 months or study duration	Yes
Secondary	Determine if there are any differences in the adverse effects profile of children with FASD compared to the overall profile for atomoxetine.		12 months or study duration	Yes
Secondary	Determine if changes in behavior seen with short-term (eight weeks) treatment of children are maintained over a twelve month period.		12 months or study duration	No
Secondary	Compare growth while on atomoxetine with growth before entry into study.		12 months or study duration	Yes