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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00418262
Other study ID # B4Z-MC-X050
Secondary ID
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


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
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