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Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-089
Placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Site Reference ID/Investigator# 7546
  • Site Reference ID/Investigator# 7551
  • Site Reference ID/Investigator# 7553
  • Site Reference ID/Investigator# 7545
  • Site Reference ID/Investigator# 7552
  • Site Reference ID/Investigator# 7548
  • Site Reference ID/Investigator# 7554
  • Site Reference ID/Investigator# 7547
  • Site Reference ID/Investigator# 7555
  • Site Reference ID/Investigator# 7549
  • Site Reference ID/Investigator# 7550
  • Site Reference ID/Investigator# 7631

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

CAARS: Inv Total Score

Secondary Outcome Measures

CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self
TASS, AAQoL, WPAI
BRIEF-A, FTND
QSU-Brief, Number of Cigarettes smoked per day

Full Information

First Posted
March 18, 2008
Last Updated
January 10, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT00640185
Brief Title
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will take one or two placebos once daily for the duration of the study.
Primary Outcome Measure Information:
Title
CAARS: Inv Total Score
Time Frame
Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
Secondary Outcome Measure Information:
Title
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
Title
TASS, AAQoL, WPAI
Time Frame
Day -1, Day 28, Day 56
Title
BRIEF-A, FTND
Time Frame
Day-1, Day 56
Title
QSU-Brief, Number of Cigarettes smoked per day
Time Frame
Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earle Bain
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 7546
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Site Reference ID/Investigator# 7551
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Reference ID/Investigator# 7553
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 7545
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Site Reference ID/Investigator# 7552
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Site Reference ID/Investigator# 7548
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Site Reference ID/Investigator# 7554
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site Reference ID/Investigator# 7547
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Reference ID/Investigator# 7555
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Site Reference ID/Investigator# 7549
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Site Reference ID/Investigator# 7550
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Site Reference ID/Investigator# 7631
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22795204
Citation
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.
Results Reference
derived

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Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

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