Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD (B4Z-US-050)

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 Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Fetal Alcohol Syndrome
• Intervention / Treatment: Drug: Atomoxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • OU Child Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Atomoxetine HCL (Strattera); Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)	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.; Other Names: Brand Name: Strattera, Serial Number: 76306506, ACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburg Side-Effects Scale: Motor Tics	Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale-Buccal, Lingual Movements	Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.	12 months or study duration
Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers	Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Worried/Anxious	Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Dull/Tired/Listless	Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Headaches	Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Stomachaches	Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Crabby/Irritable	Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed	Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Socially Withdrawn	Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Hallucinations	Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Loss of Appetite	Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation	12 months or study duration
Pittsburg Side-Effects Scale: Trouble Sleeping	Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.	12 months or study duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.	Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.	12 months or study duration
Compare Growth While on Atomoxetine With Growth Before Entry Into Study.	Height measured in centimeters at the time of each visit as part of the vital signs.	12 months or study duration

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Mark L. Wolraich
• Investigators: Principal Investigator: Laura J McGuinn, M.D., University of Oklahoma

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (ACTUAL): April 22, 2015
• Study Completion (ACTUAL): April 22, 2015

Study Registration Dates

• First Submitted: January 2, 2007
• First Submitted That Met QC Criteria: January 3, 2007
• First Posted (ESTIMATE): January 4, 2007

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: ADHD; FAS; FASD; ADD; fetal alcohol syndrome; attention deficit disorder; attention deficit disorder with hyperactivity
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Neurologic Manifestations; Disease; Dyskinesias; Fetal Diseases; Pregnancy Complications; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Alcohol-Induced Disorders; Syndrome; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Fetal Alcohol Spectrum Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 2112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO