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Completed

NCT Number: NCT00443391

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

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

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 6109, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-089

Drug

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

Primary outcomes

  1. CAARS:INV

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

  2. CGI-ADHD-S

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

Secondary outcomes

  1. AAQoL

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

  2. WPAI

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

  3. RUQ

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

  4. FTND

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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2007
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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