Fetal Alcohol SyndromePhase 3B4Z-US-050NCT00418262

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

A Phase 3 study testing Atomoxetine in people with Fetal Alcohol Syndrome and Attention Deficit Hyperactivity Disorder (ADHD), run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome. Read more about this study

Who is it for?: Ages 4 to 11 years
Conditions the study is for: Fetal Alcohol Syndrome, Attention Deficit Hyperactivity Disorder (ADHD)
What is being tested?: Atomoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Aug 2005to 22 Apr 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

OU Child Study Center
Oklahoma City, Oklahoma, 73117

Other trials in United States

About this study

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.

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

Read the 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.

Conditions: Fetal Alcohol Syndrome, Attention Deficit Hyperactivity Disorder (ADHD)
Being tested: Atomoxetine
Keywords: fetal alcohol syndrome, attention deficit disorder, attention deficit disorder with hyperactivity, ADD, FAS, FASD, ADHD
Medical subject headings: Fetal Alcohol Spectrum Disorders, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtomoxetineDrug
Also called Brand Name: Strattera, Serial Number: 76306506, ACT
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.

Study groups in NCT00418262
Study group	Role	What they receive
Atomoxetine HCL (Strattera)	Experimental	Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera) Receives: Drug: Atomoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Pittsburg Side-Effects Scale: Motor Tics
Motor Tics
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
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.
Measured: 12 months or study duration
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.
Measured: 12 months or study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 200522 Apr 2015

First posted4 Jan 2007 (estimated)
Study startAug 2005
Primary completion22 Apr 2015
Study completion22 Apr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fetal Alcohol SyndromeStudies of the same condition, open and under way.
More trials run by University of OklahomaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: open label
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00418262
Sponsor's protocol ID: 2112
Acronym: B4Z-US-050
Status last verified: Jun 2017
First submitted: 2 Jan 2007
Last updated: 2 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingPhase 2
FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
Recruiting
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
Fetal Alcohol Spectrum Disorders
Recruiting
The Synchrony Study: Examining Music Training for Children With FASD
Fetal Alcohol Spectrum Disorders

All Fetal Alcohol Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00418262
Acronym / sponsor ID: B4Z-US-050 / 2112
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Collaborators: Mark L. Wolraich
Study start: Aug 2005
Primary completion: 22 Apr 2015 (actual)
Study completion: 22 Apr 2015 (actual)
First posted: 4 Jan 2007 (estimated)
Results: Posted 2 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: open label

Arm	Type	Receives
Atomoxetine HCL (Strattera)	Experimental	Drug: AtomoxetineTeatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)

Who may qualify

Ages: 4 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtomoxetineAlso: Brand Name: Strattera, Serial Number: 76306506, ACTTitrating 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.	Drug	Atomoxetine HCL (Strattera)

Primary outcome

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.

2 secondary outcomes

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
Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
Time frame: 12 months or study duration

Results and safety

Results posted to the registry on 2 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atomoxetine HCL (Strattera)	27	25

Primary outcome: Pittsburg Side-Effects Scale: Motor Tics

Time frame: 12 months or study duration. Mean (Standard Deviation). Unit: units on a scale

Measure	Atomoxetine HCL (Strattera) n = 26
Visit 1	0.15 (0.54)
Visit 5	0.20 (0.50)
Visit 8	0.31 (0.60)
Visit 10	0.27 (0.47)

Atomoxetine HCL (Strattera): Mean Difference (Net): 0.05 (95% CI -0.21 to 0.30)
Atomoxetine HCL (Strattera): Mean Difference (Net): 0.11 (95% CI -0.42 to 0.60)

Population analysed: Children with FAS participating in the extend safety efficacy study

Primary outcome: Pittsburg Side-Effects Scale-Buccal, Lingual Movements

Time frame: 12 months or study duration. Mean (Standard Deviation). Unit: units on a scale

Measure	Atomoxetine HCL (Strattera) n = 26
Visit 1	.12 (.33)
Visit 5	0.2 (0.50)
Visit 8	0.44 (0.73)
Visit 10	0.27 (0.47)

Atomoxetine HCL (Strattera): Mean Difference (Net): 0.12 (95% CI -0.11 to 0.39)
Atomoxetine HCL (Strattera): Mean Difference (Net): 0.24 (95% CI -0.23 to 0.77)

Population analysed: Attrition

Primary outcome: Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers

Time frame: 12 months or study duration. Mean (Standard Deviation). Unit: units on a scale

Measure	Atomoxetine HCL (Strattera) n = 26
Visit 1	0.42 (0.70)
Visit 5	0.40 (0.58)
Visit 8	0.62 (0.89)
Visit 10	0.64 (1.03)

Atomoxetine HCL (Strattera): Mean Difference (Net): 0.10 (95% CI -0.17 to 0.36)
Atomoxetine HCL (Strattera): Mean Difference (Net): 0.10 (95% CI -0.17 to 0.36)

Population analysed: 27 IN PCT and one subject did not enroll in the safety efficacy study

Primary outcome: Pittsburg Side-Effects Scale: Worried/Anxious

Time frame: 12 months or study duration. Mean (Standard Deviation). Unit: units on a scale

Measure	Atomoxetine HCL (Strattera) n = 26
Visit 1	0.27 (0.45)
Visit 5	0.24 (0.60)
Visit 8	0.56 (0.63)
Visit 10	0.45 (0.69)

Atomoxetine HCL (Strattera): Mean Difference (Net): 0.13 (95% CI -0.16 to 0.40)
Atomoxetine HCL (Strattera): Mean Difference (Net): 0.13 (95% CI -0.16 to 0.40)

Population analysed: One subject from RCT did not enroll in the open label study

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atomoxetine HCL (Strattera)	0 of 26 (0%)	19 of 26 (73.1%)	0 of 26

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Fetal Alcohol Syndrome

RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura J McGuinn, M.D. principal investigator

University of Oklahoma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atomoxetine in people with Fetal Alcohol Syndrome and Attention Deficit Hyperactivity Disorder (ADHD), run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburg Side-Effects Scale: Motor Tics (time frame: 12 months or study duration). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00418262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.