NCT00640185

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

March 18, 2008

Last Update Submit

January 10, 2013

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • CAARS: Inv Total Score

    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

    Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56

  • TASS, AAQoL, WPAI

    Day -1, Day 28, Day 56

  • BRIEF-A, FTND

    Day-1, Day 56

  • QSU-Brief, Number of Cigarettes smoked per day

    Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Study Arms (3)

1

PLACEBO COMPARATOR
Drug: ABT-089Drug: Placebo

2

EXPERIMENTAL
Drug: ABT-089Drug: Placebo

3

EXPERIMENTAL
Drug: ABT-089Drug: Placebo

Interventions

ABT-089DRUG

Subjects will take up to two 40 mg tablets once daily for 8 weeks.

123
PlaceboDRUG

Subjects will take one or two placebos once daily for the duration of the study.

123

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Site Reference ID/Investigator# 7546

Lafayette, California, 94549, United States

Location

Site Reference ID/Investigator# 7551

Jacksonville, Florida, 32216, United States

Location

Site Reference ID/Investigator# 7553

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 7545

Overland Park, Kansas, 66212, United States

Location

Site Reference ID/Investigator# 7552

Farmington Hills, Michigan, 48336, United States

Location

Site Reference ID/Investigator# 7548

Troy, Michigan, 48085, United States

Location

Site Reference ID/Investigator# 7554

Eugene, Oregon, 97401, United States

Location

Site Reference ID/Investigator# 7547

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 7555

Memphis, Tennessee, 38119, United States

Location

Site Reference ID/Investigator# 7549

Virginia Beach, Virginia, 23452, United States

Location

Site Reference ID/Investigator# 7550

Bellevue, Washington, 98007, United States

Location

Site Reference ID/Investigator# 7631

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 22795204DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

pozanicline

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Earle Bain

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(12)