NCT00443391

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

21 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

February 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

March 2, 2007

Last Update Submit

January 10, 2013

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (2)

  • CAARS:INV

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

  • CGI-ADHD-S

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

Secondary Outcomes (4)

  • AAQoL

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

  • WPAI

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

  • RUQ

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

  • FTND

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

Study Arms (1)

1

EXPERIMENTAL
Drug: ABT-089

Interventions

ABT-089DRUG

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

1

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Site Reference ID/Investigator# 6109

Mesa, Arizona, 85210, United States

Location

Site Reference ID/Investigator# 6765

Mesa, Arizona, 85210, United States

Location

Site Reference ID/Investigator# 6100

Lafayette, California, 94549, United States

Location

Site Reference ID/Investigator# 6107

San Diego, California, 92103-8620, United States

Location

Site Reference ID/Investigator# 6112

Jacksonville, Florida, 32216, United States

Location

Site Reference ID/Investigator# 6096

Maitland, Florida, 32751, United States

Location

Site Reference ID/Investigator# 6105

Tampa, Florida, 33606, United States

Location

Site Reference ID/Investigator# 6094

Smyrna, Georgia, 30080, United States

Location

Site Reference ID/Investigator# 6111

Newton, Kansas, 67114, United States

Location

Site Reference ID/Investigator# 6113

Farmington Hills, Michigan, 48336, United States

Location

Site Reference ID/Investigator# 6110

Omaha, Nebraska, 68198, United States

Location

Site Reference ID/Investigator# 6099

New York, New York, 10010, United States

Location

Site Reference ID/Investigator# 6106

Chapel Hill, North Carolina, 27514, United States

Location

Site Reference ID/Investigator# 6102

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 6097

Charleston, South Carolina, 29405, United States

Location

Site Reference ID/Investigator# 6098

Memphis, Tennessee, 38119, United States

Location

Site Reference ID/Investigator# 6103

Austin, Texas, 78704, United States

Location

Site Reference ID/Investigator# 6104

Lake Jackson, Texas, 77566, United States

Location

Site Reference ID/Investigator# 6095

Herndon, Virginia, 20170, United States

Location

Site Reference ID/Investigator# 6092

Seattle, Washington, 98104, United States

Location

Site Reference ID/Investigator# 6101

Middleton, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

pozanicline

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Laura Gault, MD, PhD, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

February 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(21)