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.
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | OU Child Study Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | Eli Lilly and Company, Mark L. Wolraich |
United States,
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 |
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