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Long Term 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
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 focused on measuring Attention-Deficit/Hyperactivity Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • The subject was randomized into Study M10-346 and completed the study.
  • Female subjects of childbearing 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.
  • The subject is judged to be in generally good health.

Exclusion Criteria:

  • The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study.
  • The subject anticipates a move outside the geographic area.

Sites / Locations

  • Site Reference ID/Investigator# 8315
  • Site Reference ID/Investigator# 8306
  • Site Reference ID/Investigator# 8308
  • Site Reference ID/Investigator# 8314
  • Site Reference ID/Investigator# 8307
  • Site Reference ID/Investigator# 8318
  • Site Reference ID/Investigator# 8309
  • Site Reference ID/Investigator# 8316
  • Site Reference ID/Investigator# 8310
  • Site Reference ID/Investigator# 8319
  • Site Reference ID/Investigator# 8305
  • Site Reference ID/Investigator# 8320

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

CAARS:Inv
CGI-ADHD-S

Secondary Outcome Measures

CAARS:Self
BRIEF-A
AAQOL
WPAI
FTND

Full Information

First Posted
May 28, 2008
Last Updated
January 11, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT00686933
Brief Title
Long Term 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 for Subjects Completing Study M10-346
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in 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
Keywords
Attention-Deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
Subjects will take up to 80 mg daily for 24 months
Primary Outcome Measure Information:
Title
CAARS:Inv
Time Frame
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Title
CGI-ADHD-S
Time Frame
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Secondary Outcome Measure Information:
Title
CAARS:Self
Time Frame
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Title
BRIEF-A
Time Frame
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
Title
AAQOL
Time Frame
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
Title
WPAI
Time Frame
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
Title
FTND
Time Frame
Day -1, Month 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
No
Eligibility Criteria
Inclusion Criteria: The subject was randomized into Study M10-346 and completed the study. Female subjects of childbearing 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. The subject is judged to be in generally good health. Exclusion Criteria: The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 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
Earle Bain, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 8315
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Site Reference ID/Investigator# 8306
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Reference ID/Investigator# 8308
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 8314
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Site Reference ID/Investigator# 8307
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Site Reference ID/Investigator# 8318
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Site Reference ID/Investigator# 8309
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site Reference ID/Investigator# 8316
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Reference ID/Investigator# 8310
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Site Reference ID/Investigator# 8319
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Site Reference ID/Investigator# 8305
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Site Reference ID/Investigator# 8320
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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