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

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

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: ABT-089

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Site Reference ID/Investigator# 6109
    • Mesa, Arizona, United States, 85210
      • Site Reference ID/Investigator# 6765
  • California
    • Lafayette, California, United States, 94549
      • Site Reference ID/Investigator# 6100
    • San Diego, California, United States, 92103-8620
      • Site Reference ID/Investigator# 6107
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Site Reference ID/Investigator# 6112
    • Maitland, Florida, United States, 32751
      • Site Reference ID/Investigator# 6096
    • Tampa, Florida, United States, 33606
      • Site Reference ID/Investigator# 6105
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • Site Reference ID/Investigator# 6094
  • Kansas
    • Newton, Kansas, United States, 67114
      • Site Reference ID/Investigator# 6111
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Site Reference ID/Investigator# 6113
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Site Reference ID/Investigator# 6110
  • New York
    • New York, New York, United States, 10010
      • Site Reference ID/Investigator# 6099
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Site Reference ID/Investigator# 6106
  • Oregon
    • Portland, Oregon, United States, 97210
      • Site Reference ID/Investigator# 6102
  • South Carolina
    • Charleston, South Carolina, United States, 29405
      • Site Reference ID/Investigator# 6097
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Site Reference ID/Investigator# 6098
  • Texas
    • Austin, Texas, United States, 78704
      • Site Reference ID/Investigator# 6103
    • Lake Jackson, Texas, United States, 77566
      • Site Reference ID/Investigator# 6104
  • Virginia
    • Herndon, Virginia, United States, 20170
      • Site Reference ID/Investigator# 6095
  • Washington
    • Seattle, Washington, United States, 98104
      • Site Reference ID/Investigator# 6092
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Site Reference ID/Investigator# 6101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: ABT-089; Open label study, subjects will take up to 80mg daily for 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Laura Gault, MD, PhD, MD, AbbVie

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 2, 2007
• First Submitted That Met QC Criteria: March 2, 2007
• First Posted (Estimate): March 6, 2007

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 10, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: ADHD
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: M06-889

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No