Attention-Deficit/Hyperactivity DisorderPhase 2NCT00554385
A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing ABT-089 in people with Attention-Deficit/Hyperactivity Disorder, run by Abbott at 23 sites in United States.
Trial summary
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 2007to Aug 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
- The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
- If female, subject must be practicing at least one method of birth control throughout the study.
- If female, the result of a pregnancy test is negative.
- The subject is judged to be in generally good health.
Who cannot join
- The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
- The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
- The subject has a positive urine drug screen for alcohol or drugs of abuse.
- The subject anticipates a move outside the geographic area.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Site Ref #/Investigator 6836
Austin, Texas, 78756
Site Ref #/Investigator 6791
Bellevue, Washington, 98007
Site Ref #/Investigator 6812
Boulder, Colorado, 80304
Site Ref #/Investigator 8366
Bradenton, Florida, 34208
Site Ref #/Investigator 6799
Charleston, South Carolina, 29405
Site Ref #/Investigator 6683
Clementon, New Jersey, 08021
Site Ref #/Investigator 6682
Eugene, Oregon, 97401
Site Ref #/Investigator 6835
Herndon, Virginia, 20170
Site Ref #/Investigator 6808
Jacksonville, Florida, 32216
Site Ref #/Investigator 6856
Las Vegas, Nevada, 89128
Site Ref #/Investigator 8383
Libertyville, Illinois, 60048
Site Ref #/Investigator 6800
Little Rock, Arkansas, 72205
Site Ref #/Investigator 7955
Memphis, Tennessee, 38119
Site Ref #/Investigator 6838
Middleton, Wisconsin, 53562
Site Ref #/Investigator 6802
Northbrook, Illinois, 60062
Site Ref #/Investigator 8297
Oklahoma City, Oklahoma, 73103
Site Ref #/Investigator 6902
Omaha, Nebraska, 68198
Site Ref #/Investigator 6827
Orlando, Florida, 32806
Site Ref #/Investigator 6824
Overland Park, Kansas, 66212
Site Ref #/Investigator 6811
Portland, Oregon, 97210
Site Ref #/Investigator 8701
Portland, Oregon, 97210
Site Ref #/Investigator 6681
Salem, Oregon, 97301
Site Ref #/Investigator 8428
Troy, Michigan, 48085
About this study
Official title: The Long-term Safety and Tolerability of ABT-089 in Children 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 children with ADHD.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- ABT-089
- 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
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
| 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.
ADHD-RS-IV (HV)
Measured: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
CGI-ADHD-S
Measured: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionAug 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
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Gault, M.D., Ph.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554385
- Sponsor's protocol ID
- M10-178
- Status last verified
- Aug 2011
- First submitted
- 5 Nov 2007
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. 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 Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study
- ClinicalTrials.gov ID
- NCT00554385
- Acronym / sponsor ID
- M10-178
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 283 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 6 Nov 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 children 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
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
- If female, subject must be practicing at least one method of birth control throughout the study.
- If female, the result of a pregnancy test is negative.
- The subject is judged to be in generally good health.
Key exclusion criteria (4 listed)
- The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
- The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
- The subject has a positive urine drug screen for alcohol or drugs of abuse.
- 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-089Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day. | Drug | 1 |
Primary outcome
ADHD-RS-IV (HV)
Time frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
CGI-ADHD-S
Time frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
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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, M.D., Ph.D. study director
Abbott
23 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 Abbott at 23 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 4 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: stopped early, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 was stopped early. Results are not available in the source record.
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) (time frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12). 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 23 Aug 2011.