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CompletedNCT00686933Updated Jan 21, 2013

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

A Phase 2 interventional study of ABT-089 in Attention-Deficit/Hyperactivity Disorder, sponsored by AbbVie (prior sponsor, Abbott). Completed at 12 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-01-21.

Sponsored by AbbVie (prior sponsor, Abbott) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
117
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder

Keywords

  • Attention-Deficit/Hyperactivity Disorder
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 117 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
117 participants (actual)

Study arms

  • Experimental
    1

    Drug: ABT-089

Interventions

  • DrugABT-089

    Subjects will take up to 80 mg daily for 24 months

06

What researchers measure

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

07

Study locations

12 sites
  • Site Reference ID/Investigator# 8315
    Lafayette, California 94549, United States
  • Site Reference ID/Investigator# 8306
    Jacksonville, Florida 32216, United States
  • Site Reference ID/Investigator# 8308
    Orlando, Florida 32806, United States
  • Site Reference ID/Investigator# 8314
    Overland Park, Kansas 66212, United States
  • Site Reference ID/Investigator# 8307
    Farmington Hills, Michigan 48336, United States
  • Site Reference ID/Investigator# 8318
    Troy, Michigan 48085, United States
  • Site Reference ID/Investigator# 8309
    Eugene, Oregon 97401, United States
  • Site Reference ID/Investigator# 8316
    Portland, Oregon 97210, United States
  • Site Reference ID/Investigator# 8310
    Memphis, Tennessee 38119, United States
  • Site Reference ID/Investigator# 8319
    Virginia Beach, Virginia 23452, United States
  • Site Reference ID/Investigator# 8305
    Bellevue, Washington 98007, United States
  • Site Reference ID/Investigator# 8320
    Seattle, Washington 98104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00686933
Lead sponsor
AbbVie (prior sponsor, Abbott)
Responsible party
Sponsor
First posted
May 30, 2008
Start date
May 2008
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Jan 21, 2013

Study contacts

Earle Bain, MD
study director · AbbVie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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