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Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD (B4Z-US-050)

This study has been completed.
Sponsor:
Collaborator:
Mark L. Wolraich
Information provided by (Responsible Party):
Laura J McGuinn, MD, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00418262
First received: January 2, 2007
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Condition Intervention Phase
Fetal Alcohol Syndrome Attention Deficit Hyperactivity Disorder (ADHD) Drug: Atomoxetine Phase 3

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

Resource links provided by NLM:


Further study details as provided by Laura J McGuinn, MD, University of Oklahoma:

Primary Outcome Measures:
  • Pittsburg Side-Effects Scale: Motor Tics [ Time Frame: 12 months or study duration ]

    Motor Tics

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale-Buccal, Lingual Movements [ Time Frame: 12 months or study duration ]

    Buccal, Lingual Movements

    Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.


  • Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers [ Time Frame: 12 months or study duration ]

    Movements, Picking/Chewing Skin or Fingers

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Worried/Anxious [ Time Frame: 12 months or study duration ]

    Worried/Anxious

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Dull/Tired/Listless [ Time Frame: 12 months or study duration ]

    Dull/Tired/Listless

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Headaches [ Time Frame: 12 months or study duration ]

    Headaches

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Stomachaches [ Time Frame: 12 months or study duration ]

    Stomachaches

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Crabby/Irritable [ Time Frame: 12 months or study duration ]

    Crabby/Irritable

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Tearful/Sad/Depressed [ Time Frame: 12 months or study duration ]

    Tearful/Sad/Depressed

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Socially Withdrawn [ Time Frame: 12 months or study duration ]

    Socially Withdrawn

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Hallucinations [ Time Frame: 12 months or study duration ]

    Hallucinations

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Loss of Appetite [ Time Frame: 12 months or study duration ]

    Loss of Appetite

    Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation


  • Pittsburg Side-Effects Scale: Trouble Sleeping [ Time Frame: 12 months or study duration ]
    Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.


Secondary Outcome Measures:
  • Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. [ Time Frame: 12 months or study duration ]
    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.

  • Compare Growth While on Atomoxetine With Growth Before Entry Into Study. [ Time Frame: 12 months or study duration ]
    Height measured in centimeters at the time of each visit as part of the vital signs.


Enrollment: 27
Study Start Date: August 2005
Study Completion Date: April 22, 2015
Primary Completion Date: April 22, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atomoxetine HCL (Strattera)
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Drug: Atomoxetine
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.
Other Name: Brand Name: Strattera, Serial Number: 76306506, ACT

Detailed 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.
  Eligibility

Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418262

Locations
United States, Oklahoma
OU Child Study Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
Mark L. Wolraich
Investigators
Principal Investigator: Laura J McGuinn, M.D. University of Oklahoma
  More Information

Responsible Party: Laura J McGuinn, MD, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00418262     History of Changes
Other Study ID Numbers: 2112
Study First Received: January 2, 2007
Results First Received: June 2, 2017
Last Updated: June 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Laura J McGuinn, MD, University of Oklahoma:
fetal alcohol syndrome
attention deficit disorder
attention deficit disorder with hyperactivity
ADD
FAS
FASD
ADHD

Additional relevant MeSH terms:
Syndrome
Fetal Alcohol Spectrum Disorders
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pregnancy Complications
Substance-Related Disorders
Chemically-Induced Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017