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A Safety and Tolerability 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

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD

Eligibility Criteria

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

Inclusion Criteria:

The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
If female, the result of a pregnancy tests are negative
The subject is judged to be in generally good health

Exclusion Criteria:

More than 7 days have elapsed since the last dose of study drug in Study M06-855
The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
The subject anticipates a move outside the geographic area

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

CAARS:INV

CGI-ADHD-S

Secondary Outcome Measures

AAQoL

WPAI

RUQ

FTND

Full Information

NCT ID

NCT00443391

First Posted

March 2, 2007

Last Updated

January 10, 2013

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT00443391

Brief Title

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

Official Title

The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

5. Study Description

Brief Summary

The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ABT-089

Intervention Description

Open label study, subjects will take up to 80mg daily for 24 months.

Primary Outcome Measure Information:

Title

CAARS:INV

Time Frame

Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Title

CGI-ADHD-S

Time Frame

Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Secondary Outcome Measure Information:

Title

AAQoL

Time Frame

Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24

Title

WPAI

Time Frame

Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24

Title

RUQ

Time Frame

Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24

Title

FTND

Time Frame

Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study If female, the result of a pregnancy tests are negative The subject is judged to be in generally good health Exclusion Criteria: More than 7 days have elapsed since the last dose of study drug in Study M06-855 The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study The subject anticipates a move outside the geographic area

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Gault, MD, PhD, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 6109

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Site Reference ID/Investigator# 6765

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Site Reference ID/Investigator# 6100

City

Lafayette

State/Province

California

ZIP/Postal Code

94549

Country

United States

Facility Name

Site Reference ID/Investigator# 6107

City

San Diego

State/Province

California

ZIP/Postal Code

92103-8620

Country

United States

Facility Name

Site Reference ID/Investigator# 6112

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Site Reference ID/Investigator# 6096

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Site Reference ID/Investigator# 6105

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Site Reference ID/Investigator# 6094

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30080

Country

United States

Facility Name

Site Reference ID/Investigator# 6111

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Site Reference ID/Investigator# 6113

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48336

Country

United States

Facility Name

Site Reference ID/Investigator# 6110

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Site Reference ID/Investigator# 6099

City

New York

State/Province

New York

ZIP/Postal Code

10010

Country

United States

Facility Name

Site Reference ID/Investigator# 6106

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Site Reference ID/Investigator# 6102

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Site Reference ID/Investigator# 6097

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29405

Country

United States

Facility Name

Site Reference ID/Investigator# 6098

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Site Reference ID/Investigator# 6103

City

Austin

State/Province

Texas

ZIP/Postal Code

78704

Country

United States

Facility Name

Site Reference ID/Investigator# 6104

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

Country

United States

Facility Name

Site Reference ID/Investigator# 6095

City

Herndon

State/Province

Virginia

ZIP/Postal Code

20170

Country

United States

Facility Name

Site Reference ID/Investigator# 6092

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Site Reference ID/Investigator# 6101

City

Middleton

State/Province

Wisconsin

ZIP/Postal Code

53562

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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

Attention Deficit Hyperactivity Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial