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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)

Primary Purpose

Fetal Alcohol Syndrome, Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Alcohol Syndrome focused on measuring fetal alcohol syndrome, attention deficit disorder, attention deficit disorder with hyperactivity, ADD, FAS, FASD, ADHD

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OU Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atomoxetine HCL (Strattera)

Arm Description

Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)

Outcomes

Primary Outcome Measures

Pittsburg Side-Effects Scale: Motor Tics
Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale-Buccal, Lingual Movements
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
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
Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Dull/Tired/Listless
Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Headaches
Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Stomachaches
Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Crabby/Irritable
Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Socially Withdrawn
Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Hallucinations
Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Loss of Appetite
Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Trouble Sleeping
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.
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.
Height measured in centimeters at the time of each visit as part of the vital signs.

Full Information

First Posted
January 2, 2007
Last Updated
June 2, 2017
Sponsor
University of Oklahoma
Collaborators
Mark L. Wolraich
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1. Study Identification

Unique Protocol Identification Number
NCT00418262
Brief Title
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
Acronym
B4Z-US-050
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 22, 2015 (Actual)
Study Completion Date
April 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma
Collaborators
Mark L. Wolraich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Syndrome, Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
fetal alcohol syndrome, attention deficit disorder, attention deficit disorder with hyperactivity, ADD, FAS, FASD, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomoxetine HCL (Strattera)
Arm Type
Experimental
Arm Description
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Brand Name: Strattera, Serial Number: 76306506, ACT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pittsburg Side-Effects Scale: Motor Tics
Description
Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale-Buccal, Lingual Movements
Description
Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
Description
Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Worried/Anxious
Description
Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Dull/Tired/Listless
Description
Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Headaches
Description
Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Stomachaches
Description
Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Crabby/Irritable
Description
Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
Description
Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Socially Withdrawn
Description
Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Hallucinations
Description
Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Loss of Appetite
Description
Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time Frame
12 months or study duration
Title
Pittsburg Side-Effects Scale: Trouble Sleeping
Description
Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.
Time Frame
12 months or study duration
Secondary Outcome Measure Information:
Title
Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.
Description
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.
Time Frame
12 months or study duration
Title
Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
Description
Height measured in centimeters at the time of each visit as part of the vital signs.
Time Frame
12 months or study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura J McGuinn, M.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
OU Child Study Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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