Fetal Alcohol SyndromePhase 1B4Z-MC-X017NCT00417794
Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
A Phase 1 study testing Strattera in people with Fetal Alcohol Syndrome and Attention Deficit Disorder With Hyperactivity (ADHD), run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Fetal Alcohol Syndrome, Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)
- What is being tested?
- Strattera
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to 22 Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 be between the ages of 4 and 11 years at the time of entry into the study.
- Patients must meet diagnostic criteria for FASD
- Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of > or = to 90%ile for age and gender for either subtest or total score if greater than 5 years of age.
- Patients who enter the study at visit 1 taking stimulant medication must be medication-free for at least 24 hours before visit 2.
- 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 developmental level (~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. Children less than 6 years old must have completed a course of PCIT and still meet DSM-IV criteria for ADHD.
Who cannot join
- Have received an in investigational medication in the past 30 days.
- Are currently on a medication treatment that is effective (ADHDRS-IV score within 1 SD of average) and well tolerated.
- Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
- Have used MAOIs within one month prior to visit 2.
- Patients with hypertension.
- Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder.
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- 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 2.
- 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
About this study
Official title: A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
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 disorder (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 Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)
- Being tested
- Strattera, Placebo
- Keywords
- attention deficit hyperactivity disorder, ADHD, fetal alcohol syndrome, FAS, FASD, atomoxetine hcl
- 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.
StratteraDrug
Also called atomoxetine HCL
escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy
PlaceboDrug
0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Atomoxetine HCL (Strattera) Receives: Drug: Strattera |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale - IV
Measured: length of protocol
Secondary outcomes (6)
Determine if atomoxetine is safe and well tolerated by children with FAS.
Measured: length of protocol
Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo.
Measured: length of protocol
Determine if atomoxetine improves behaviors in the mornings and evenings.
Measured: Length of protocol
Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.
Measured: Length of protocol
Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine.
Measured: Length of protocol
Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI)
Measured: Length of protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- 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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Mark L. Wolraich, M.D., Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Laura J McGuinn, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417794
- Sponsor's protocol ID
- 2115
- Acronym
- B4Z-MC-X017
- Status last verified
- Apr 2017
- First submitted
- 2 Jan 2007
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects
- ClinicalTrials.gov ID
- NCT00417794
- Acronym / sponsor ID
- B4Z-MC-X017 / 2115
- Conditions
- Fetal Alcohol Syndrome, Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)
- Keywords
- attention deficit hyperactivity disorder, ADHD, fetal alcohol syndrome, FAS, FASD, atomoxetine hcl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Mark L. Wolraich, M.D., Eli Lilly and Company
- Study start
- Aug 2005
- Primary completion
- 22 Apr 2015 (actual)
- Study completion
- 22 Apr 2015 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
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 disorder (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: StratteraAtomoxetine HCL (Strattera) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patient must be between the ages of 4 and 11 years at the time of entry into the study.
- Patients must meet diagnostic criteria for FASD
- Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of > or = to 90%ile for age and gender for either subtest or total score if greater than 5 years of age.
- Patients who enter the study at visit 1 taking stimulant medication must be medication-free for at least 24 hours before visit 2.
- History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study.
Key exclusion criteria (10 listed)
- Have received an in investigational medication in the past 30 days.
- Are currently on a medication treatment that is effective (ADHDRS-IV score within 1 SD of average) and well tolerated.
- Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
- Have used MAOIs within one month prior to visit 2.
- Patients with hypertension.
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 |
|---|---|---|
| StratteraAlso: atomoxetine HCLescalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy | Drug | 1 |
| Placebo0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast. | Drug | 2 |
Primary outcome
ADHD Rating Scale - IV
Time frame: length of protocol
6 secondary outcomes
Determine if atomoxetine is safe and well tolerated by children with FAS.
Time frame: length of protocol
Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo.
Time frame: length of protocol
Determine if atomoxetine improves behaviors in the mornings and evenings.
Time frame: Length of protocol
Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.
Time frame: Length of protocol
Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine.
Time frame: Length of protocol
Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: Length of protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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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, PhD 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 1 study testing Strattera in people with Fetal Alcohol Syndrome and Attention Deficit Disorder With Hyperactivity (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 10 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 10 Apr 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ADHD Rating Scale - IV (time frame: length of protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2017.