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

NCT00418262 | Completed Phase 3 Results DMC

• 1 other identifier: 2112
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fetal Alcohol Syndrome; Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

fetal alcohol syndrome; attention deficit disorder; attention deficit disorder with hyperactivity; ADD; FAS; FASD; ADHD

Outcome Measures

Primary Outcomes (13)

• Pittsburg Side-Effects Scale: Motor Tics

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

  12 months or study duration

• 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.

  12 months or study duration

• 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

  12 months or study duration

• Pittsburg Side-Effects Scale: Worried/Anxious

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

  12 months or study duration

• 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

  12 months or study duration

• Pittsburg Side-Effects Scale: Headaches

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

  12 months or study duration

• Pittsburg Side-Effects Scale: Stomachaches

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

  12 months or study duration

• Pittsburg Side-Effects Scale: Crabby/Irritable

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

  12 months or study duration

• 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

  12 months or study duration

• Pittsburg Side-Effects Scale: Socially Withdrawn

  Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

  12 months or study duration

• Pittsburg Side-Effects Scale: Hallucinations

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

  12 months or study duration

• 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

  12 months or study duration

• Pittsburg Side-Effects Scale: Trouble Sleeping

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

  12 months or study duration

Secondary Outcomes (2)

• 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

• Compare Growth While on Atomoxetine With Growth Before Entry Into Study.

  12 months or study duration

Study Arms (1)

Atomoxetine HCL (Strattera)

EXPERIMENTAL

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

Drug: Atomoxetine

Interventions

Atomoxetine DRUG

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.

Also known as: Brand Name: Strattera, Serial Number: 76306506, ACT

Atomoxetine HCL (Strattera)

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Mark L. Wolraich: collaborator

Study Sites (1)

OU Child Study Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

There were a limited number of subjects because of difficulties in recruiting children with FAS and ADHD within the age group studied. We were only able to obtain a small number of teacher rating scales.

Results Point of Contact

• Title: Mark Wolraich, M.D.
• Organization: University of Oklahoma Health Sciences Center

mark-wolraich@ouhsc.edu

(405) 271-5700

Study Officials

• Laura J McGuinn, M.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: open label

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: August 1, 2005
• Primary Completion: April 22, 2015
• Study Completion: April 22, 2015
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)