Attention-Deficit/Hyperactivity DisorderPhase 2NCT00528697
A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing ABT-089 and atomoxetine in people with Attention-Deficit/Hyperactivity Disorder, run by AbbVie (prior sponsor, Abbott) at 20 sites in United States.
Trial summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- ABT-089 and atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 20 sitesUnited States
- Study dates
- Sep 2007to Apr 2008
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have voluntarily signed an informed consent form
- Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s)
- First grade or higher in a school setting 3 days/week
- Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
- Subject weighs at least 37 pounds (17 kg)
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements
- Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations
Who cannot join
- Subject is not functioning at an age-appropriate level intellectually
- Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
- Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
- Subject has a history of significant allergic reaction to any drug
- Subject requires ongoing treatment with any psychiatric medication
- Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Site Reference ID/Investigator# 6000
Austin, Texas, 78756
Site Reference ID/Investigator# 5978
Bellevue, Washington, 98007
Site Reference ID/Investigator# 5986
Boulder, Colorado, 80304
Site Reference ID/Investigator# 5993
Bradenton, Florida, 34208
Site Reference ID/Investigator# 5994
Charleston, South Carolina, 29405
Site Reference ID/Investigator# 5987
Clementon, New Jersey, 08021
Site Reference ID/Investigator# 5979
El Centro, California, 92243
Site Reference ID/Investigator# 5996
Eugene, Oregon, 97401
Site Reference ID/Investigator# 5998
Herndon, Virginia, 20170
Site Reference ID/Investigator# 5995
Jacksonville, Florida, 32216
Site Reference ID/Investigator# 5997
Las Vegas, Nevada, 89128
Site Reference ID/Investigator# 5999
Little Rock, Arkansas, 72205
Site Reference ID/Investigator# 5976
Memphis, Tennessee, 38119
Site Reference ID/Investigator# 5983
Middleton, Wisconsin, 53562
Site Reference ID/Investigator# 5981
Northbrook, Illinois, 60062
Site Reference ID/Investigator# 5992
Omaha, Nebraska, 68198
Site Reference ID/Investigator# 5977
Orlando, Florida, 32806
Site Reference ID/Investigator# 5982
Overland Park, Kansas, 66212
Site Reference ID/Investigator# 5984
Portland, Oregon, 97210
Site Reference ID/Investigator# 5980
Salem, Oregon, 97301
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- ABT-089, atomoxetine, placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-089Drug
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
atomoxetineDrug
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
placeboDrug
Subject will take a tablet once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lowest ABT-089 dose Receives: Drug: ABT-089 |
| 2 | Experimental | Low-medium ABT-089 dose Receives: Drug: ABT-089 |
| 3 | Experimental | Medium-high ABT-089 dose Receives: Drug: ABT-089 |
| 4 | Experimental | Highest ABT-089 dose Receives: Drug: ABT-089 |
| 5 | Active comparator | atomoxetine Receives: Drug: atomoxetine |
| 6 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-RS-IV (HV) - Administered by study doctor
Measured: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Secondary outcomes (4)
Health Outcomes Measurements
Measured: Baseline to Final Evaluation of 8-week treatment period
Clinical Global Impression-ADHD-Severity Scale
Measured: Baseline to Final Evaluation of 8-week treatment period
Parent Rating Scales
Measured: Baseline to Final Evaluation of 8-week treatment period
Teacher Rating Scale
Measured: Baseline to Final Evaluation of 8-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Gault, MD, PhD, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528697
- Sponsor's protocol ID
- M06-888
- Status last verified
- Jan 2013
- First submitted
- 11 Sep 2007
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25.
PubMed 21156272
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00528697
- Acronym / sponsor ID
- M06-888
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Sep 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 test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-089Lowest ABT-089 dose |
| 2 | Experimental | Drug: ABT-089Low-medium ABT-089 dose |
| 3 | Experimental | Drug: ABT-089Medium-high ABT-089 dose |
| 4 | Experimental | Drug: ABT-089Highest ABT-089 dose |
| 5 | Active comparator | Drug: atomoxetineatomoxetine |
| 6 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Have voluntarily signed an informed consent form
- Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s)
- First grade or higher in a school setting 3 days/week
- Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
- Subject weighs at least 37 pounds (17 kg)
Key exclusion criteria (6 listed)
- Subject is not functioning at an age-appropriate level intellectually
- Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
- Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
- Subject has a history of significant allergic reaction to any drug
- Subject requires ongoing treatment with any psychiatric medication
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 |
|---|---|---|
| ABT-089Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks. | Drug | 1, 2, 3, 4 |
| atomoxetineSubjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks. | Drug | 5 |
| placeboSubject will take a tablet once daily for 8 weeks | Drug | 6 |
Primary outcome
ADHD-RS-IV (HV) - Administered by study doctor
Time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
4 secondary outcomes
Health Outcomes Measurements
Time frame: Baseline to Final Evaluation of 8-week treatment period
Clinical Global Impression-ADHD-Severity Scale
Time frame: Baseline to Final Evaluation of 8-week treatment period
Parent Rating Scales
Time frame: Baseline to Final Evaluation of 8-week treatment period
Teacher Rating Scale
Time frame: Baseline to Final Evaluation of 8-week treatment period
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 29 Jan 2013.
- Derived from this study: PubMed 21156272Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25.
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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 Gault, MD, PhD, MD study director
AbbVie
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-089 and atomoxetine in people with Attention-Deficit/Hyperactivity Disorder, run by AbbVie (prior sponsor, Abbott) at 20 sites 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 7 inclusion and 6 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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-RS-IV (HV) - Administered by study doctor (time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56). 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 NCT00528697, which also lists 1 linked publication.
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 29 Jan 2013.