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

Study Overview
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Brief Summary
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Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Detailed Description
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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.

Official Title
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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.

Conditions
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Fetal Alcohol Syndrome, Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Drug: Atomoxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atomoxetine HCL (Strattera)<br>Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera) | Drug: Atomoxetine<br>* 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.<br>* Other names: Brand Name: Strattera, Serial Number: 76306506, ACT;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADD, fetal alcohol syndrome, attention deficit disorder, attention deficit disorder with hyperactivity, FAS, FASD, ADHD