Attention-Deficit/Hyperactivity DisorderPhase 2NCT00640185
Safety, Tolerability and Efficacy 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 purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2008to 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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 subject.
- Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
- Female subjects of child-bearing 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.
- Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.
Who cannot join
- Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
- Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
- Subject has a history of, or ongoing, serious medical problem.
- Subject has a history of significant allergic reaction to any drug.
- Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
- Subject requires ongoing treatment with any psychiatric medication.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Site Reference ID/Investigator# 7550
Bellevue, Washington, 98007
Site Reference ID/Investigator# 7554
Eugene, Oregon, 97401
Site Reference ID/Investigator# 7552
Farmington Hills, Michigan, 48336
Site Reference ID/Investigator# 7551
Jacksonville, Florida, 32216
Site Reference ID/Investigator# 7546
Lafayette, California, 94549
Site Reference ID/Investigator# 7555
Memphis, Tennessee, 38119
Site Reference ID/Investigator# 7553
Orlando, Florida, 32806
Site Reference ID/Investigator# 7545
Overland Park, Kansas, 66212
Site Reference ID/Investigator# 7547
Portland, Oregon, 97210
Site Reference ID/Investigator# 7631
Seattle, Washington, 98104
Site Reference ID/Investigator# 7548
Troy, Michigan, 48085
Site Reference ID/Investigator# 7549
Virginia Beach, Virginia, 23452
About this study
Official title: A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults 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 adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- ABT-089, 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 up to two 40 mg tablets once daily for 8 weeks.
PlaceboDrug
Subjects will take one or two placebos once daily for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: ABT-089; Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: ABT-089; Drug: Placebo |
| 3 | Experimental | Not described Receives: Drug: ABT-089; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAARS: Inv Total Score
Measured: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
Secondary outcomes (4)
CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self
Measured: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
TASS, AAQoL, WPAI
Measured: Day -1, Day 28, Day 56
BRIEF-A, FTND
Measured: Day-1, Day 56
QSU-Brief, Number of Cigarettes smoked per day
Measured: Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Earle Bain, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640185
- Sponsor's protocol ID
- M10-346
- Status last verified
- Jan 2013
- First submitted
- 18 Mar 2008
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bain EE, Apostol G, Sangal RB, Robieson WZ, McNeill DL, Abi-Saab WM, Saltarelli MD. A randomized pilot study of the efficacy and safety of ABT-089, a novel alpha4beta2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jun;73(6):783-9. doi: 10.4088/JCP.10m06719.
PubMed 22795204
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
- A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00640185
- Acronym / sponsor ID
- M10-346
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 21 Mar 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 purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: ABT-089, Drug: Placebo |
| 2 | Experimental | Drug: ABT-089, Drug: Placebo |
| 3 | Experimental | Drug: ABT-089, Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have voluntarily signed an informed consent form.
- Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.
- Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
- Female subjects of child-bearing 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.
Key exclusion criteria (6 listed)
- Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
- Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
- Subject has a history of, or ongoing, serious medical problem.
- Subject has a history of significant allergic reaction to any drug.
- Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
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 two 40 mg tablets once daily for 8 weeks. | Drug | 1, 2, 3 |
| PlaceboSubjects will take one or two placebos once daily for the duration of the study. | Drug | 1, 2, 3 |
Primary outcome
CAARS: Inv Total Score
Time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
4 secondary outcomes
CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self
Time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
TASS, AAQoL, WPAI
Time frame: Day -1, Day 28, Day 56
BRIEF-A, FTND
Time frame: Day-1, Day 56
QSU-Brief, Number of Cigarettes smoked per day
Time frame: Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
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.
- Derived from this study: PubMed 22795204Bain EE, Apostol G, Sangal RB, Robieson WZ, McNeill DL, Abi-Saab WM, Saltarelli MD. A randomized pilot study of the efficacy and safety of ABT-089, a novel alpha4beta2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jun;73(6):783-9. doi: 10.4088/JCP.10m06719.
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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 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 6 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 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 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. 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?
CAARS: Inv Total Score (time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and 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 NCT00640185, 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 18 Jan 2013.