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Completed

NCT Number: NCT00686933

Long Term 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 effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (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# 8315, Lafayette, California, 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 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.

Treatment and study plan

ABT-089

Drug

Subjects will take up to 80 mg daily for 24 months

Primary outcomes

  1. CAARS:Inv

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

  2. CGI-ADHD-S

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

Secondary outcomes

  1. CAARS:Self

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

  2. BRIEF-A

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

  3. AAQOL

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

  4. WPAI

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

  5. FTND

    Time frame: Day -1, Month 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 for Subjects Completing Study M10-346

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 30, 2008
Registry last updated
Jan 21, 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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