Attention-Deficit/Hyperactivity DisorderPhase 2NCT00686933
Long Term 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 12 sites in United States.
Trial summary
The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (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
- 117 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2008to 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 M10-346 and completed the study.
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
- Male subjects must agree to comply with applicable contraceptive requirements.
- The subject is judged to be in generally good health.
Who cannot join
- The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study.
- The subject anticipates a move outside the geographic area.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Site Reference ID/Investigator# 8305
Bellevue, Washington, 98007
Site Reference ID/Investigator# 8309
Eugene, Oregon, 97401
Site Reference ID/Investigator# 8307
Farmington Hills, Michigan, 48336
Site Reference ID/Investigator# 8306
Jacksonville, Florida, 32216
Site Reference ID/Investigator# 8315
Lafayette, California, 94549
Site Reference ID/Investigator# 8310
Memphis, Tennessee, 38119
Site Reference ID/Investigator# 8308
Orlando, Florida, 32806
Site Reference ID/Investigator# 8314
Overland Park, Kansas, 66212
Site Reference ID/Investigator# 8316
Portland, Oregon, 97210
Site Reference ID/Investigator# 8320
Seattle, Washington, 98104
Site Reference ID/Investigator# 8318
Troy, Michigan, 48085
Site Reference ID/Investigator# 8319
Virginia Beach, Virginia, 23452
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 for Subjects Completing Study M10-346
The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- ABT-089
- Keywords
- Attention-Deficit/Hyperactivity Disorder
- 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 up to 80 mg 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, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
Measured: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Secondary outcomes (5)
CAARS:Self
Measured: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
BRIEF-A
Measured: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
AAQOL
Measured: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
WPAI
Measured: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
FTND
Measured: Day -1, Month 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 posted30 May 2008 (estimated)
- Study startMay 2008
- 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Earle Bain, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686933
- Sponsor's protocol ID
- M10-425
- Status last verified
- Jan 2013
- First submitted
- 28 May 2008
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 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 for Subjects Completing Study M10-346
- ClinicalTrials.gov ID
- NCT00686933
- Acronym / sponsor ID
- M10-425
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 May 2008 (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 effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (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 M10-346 and completed the study.
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
- Male subjects must agree to comply with applicable contraceptive requirements.
- The subject is judged to be in generally good health.
Key exclusion criteria (2 listed)
- The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 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-089Subjects will take up to 80 mg daily for 24 months | Drug | 1 |
Primary outcome
CAARS:Inv
Time frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
Time frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
5 secondary outcomes
CAARS:Self
Time frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
BRIEF-A
Time frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
AAQOL
Time frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
WPAI
Time frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
FTND
Time frame: Day -1, Month 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 21 Jan 2013.
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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.
Earle Bain, MD study director
AbbVie
12 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 12 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 2 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 21 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 12 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, Month 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 21 Jan 2013.