Phase 3
N=27
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
Fetal Alcohol Syndrome · Attention Deficit Hyperactivity Disorder (ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT00418262 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Pittsburg Side-Effects Scale: Motor Tics — 0.15; 0.20; 0.31; 0.27 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atomoxetine (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pittsburg Side-Effects Scale: Motor Tics |
0.15; 0.20; 0.31; 0.27 | — |
| PRIMARY Pittsburg Side-Effects Scale-Buccal, Lingual Movements |
.12; 0.2; 0.44; 0.27 | — |
| PRIMARY Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers |
0.42; 0.40; 0.62; 0.64 | — |
| PRIMARY Pittsburg Side-Effects Scale: Worried/Anxious |
0.27; 0.24; 0.56; 0.45 | — |
| PRIMARY Pittsburg Side-Effects Scale: Dull/Tired/Listless |
0.31; 0.36; 0.38; 0.36 | — |
| PRIMARY Pittsburg Side-Effects Scale: Headaches |
0.23; 0.40; 0.31; 0.18 | — |
| PRIMARY Pittsburg Side-Effects Scale: Stomachaches |
0.23; 0.36; 0.25; 0.45 | — |
| PRIMARY Pittsburg Side-Effects Scale: Crabby/Irritable |
0.85; 0.68; 1.06; 0.73 | — |
| PRIMARY Pittsburg Side-Effects Scale: Tearful/Sad/Depressed |
0.19; 0.24; 0.50; 0.27 | — |
| PRIMARY Pittsburg Side-Effects Scale: Socially Withdrawn |
0.12; 0.16; 0.25; 0.09 | — |
| PRIMARY Pittsburg Side-Effects Scale: Hallucinations |
0.04; 0.00; 0.12; 0.00 | — |
| PRIMARY Pittsburg Side-Effects Scale: Loss of Appetite |
0.46; 0.56; 0.38; 0.45 | — |
| PRIMARY Pittsburg Side-Effects Scale: Trouble Sleeping |
0.35; 0.64; 0.53; 0.40 | — |
| SECONDARY Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. |
37.35; 27.87; 31.88 | — |
| SECONDARY Compare Growth While on Atomoxetine With Growth Before Entry Into Study. |
121.67; 123.27; 132.13 | — |
Summary
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00418262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.