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

• Status: Completed
• Trial end date: 2015-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborators: Eli Lilly and Company; Mark L. Wolraich
• Treatments: Atomoxetine Hydrochloride

Criteria

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.