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

January 11, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lafayette, California, United States, 94549
        • Site Reference ID/Investigator# 8315
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Site Reference ID/Investigator# 8306
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 8308
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 8314
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Site Reference ID/Investigator# 8307
      • Troy, Michigan, United States, 48085
        • Site Reference ID/Investigator# 8318
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site Reference ID/Investigator# 8309
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 8316
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Site Reference ID/Investigator# 8310
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • Site Reference ID/Investigator# 8319
    • Washington
      • Bellevue, Washington, United States, 98007
        • Site Reference ID/Investigator# 8305
      • Seattle, Washington, United States, 98104
        • Site Reference ID/Investigator# 8320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ABT-089
Subjects will take up to 80 mg daily for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CAARS:Inv
Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Secondary Outcome Measures

Outcome Measure
Time Frame
CAARS:Self
Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
BRIEF-A
Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
AAQOL
Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
WPAI
Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
FTND
Time Frame: Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Earle Bain, MD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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