Attention Deficit Hyperactivity DisorderPhase 2NCT00443391
A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)
A Phase 2 study testing ABT-089 in people with Attention Deficit Hyperactivity Disorder, run by AbbVie (prior sponsor, Abbott) at 21 sites in United States.
Trial summary
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- ABT-089
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 21 sitesUnited States
- Study dates
- Feb 2007to Oct 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
- If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
- If female, the result of a pregnancy tests are negative
- The subject is judged to be in generally good health
Who cannot join
- More than 7 days have elapsed since the last dose of study drug in Study M06-855
- The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
- The subject anticipates a move outside the geographic area
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Site Reference ID/Investigator# 6103
Austin, Texas, 78704
Site Reference ID/Investigator# 6106
Chapel Hill, North Carolina, 27514
Site Reference ID/Investigator# 6097
Charleston, South Carolina, 29405
Site Reference ID/Investigator# 6113
Farmington Hills, Michigan, 48336
Site Reference ID/Investigator# 6095
Herndon, Virginia, 20170
Site Reference ID/Investigator# 6112
Jacksonville, Florida, 32216
Site Reference ID/Investigator# 6100
Lafayette, California, 94549
Site Reference ID/Investigator# 6104
Lake Jackson, Texas, 77566
Site Reference ID/Investigator# 6096
Maitland, Florida, 32751
Site Reference ID/Investigator# 6098
Memphis, Tennessee, 38119
Site Reference ID/Investigator# 6109
Mesa, Arizona, 85210
Site Reference ID/Investigator# 6765
Mesa, Arizona, 85210
Site Reference ID/Investigator# 6101
Middleton, Wisconsin, 53562
Site Reference ID/Investigator# 6099
New York, New York, 10010
Site Reference ID/Investigator# 6111
Newton, Kansas, 67114
Site Reference ID/Investigator# 6110
Omaha, Nebraska, 68198
Site Reference ID/Investigator# 6102
Portland, Oregon, 97210
Site Reference ID/Investigator# 6107
San Diego, California, 92103-8620
Site Reference ID/Investigator# 6092
Seattle, Washington, 98104
Site Reference ID/Investigator# 6094
Smyrna, Georgia, 30080
Site Reference ID/Investigator# 6105
Tampa, Florida, 33606
About this study
Official title: The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- ABT-089
- Keywords
- ADHD
- 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
Open label study, subjects will take up to 80mg daily for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ABT-089 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAARS:INV
Measured: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
Measured: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Secondary outcomes (4)
AAQoL
Measured: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
WPAI
Measured: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
RUQ
Measured: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
FTND
Measured: Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 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
- NCT00443391
- Sponsor's protocol ID
- M06-889
- Status last verified
- Jan 2013
- First submitted
- 2 Mar 2007
- Last updated
- 18 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study
- ClinicalTrials.gov ID
- NCT00443391
- Acronym / sponsor ID
- M06-889
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 6 Mar 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 objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-089 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
- If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
- If female, the result of a pregnancy tests are negative
- The subject is judged to be in generally good health
Key exclusion criteria (3 listed)
- More than 7 days have elapsed since the last dose of study drug in Study M06-855
- The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
- The subject anticipates a move outside the geographic area
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-089Open label study, subjects will take up to 80mg daily for 24 months. | Drug | 1 |
Primary outcome
CAARS:INV
Time frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
Time frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
4 secondary outcomes
AAQoL
Time frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
WPAI
Time frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
RUQ
Time frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
FTND
Time frame: Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
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 18 Jan 2013.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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
21 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 in people with Attention Deficit Hyperactivity Disorder, run by AbbVie (prior sponsor, Abbott) at 21 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 4 inclusion and 3 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 18 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 21 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. 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?
CAARS:INV (time frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24). The study lists 2 primary outcomes in all. 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 18 Jan 2013.