NCT00686933

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

May 28, 2008

Last Update Submit

January 11, 2013

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

  • CAARS:Inv

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

  • CGI-ADHD-S

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

Secondary Outcomes (5)

  • CAARS:Self

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

  • BRIEF-A

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

  • AAQOL

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

  • WPAI

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

  • FTND

    Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Study Arms (1)

1

EXPERIMENTAL
Drug: ABT-089

Interventions

ABT-089DRUG

Subjects will take up to 80 mg daily for 24 months

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Site Reference ID/Investigator# 8315

Lafayette, California, 94549, United States

Location

Site Reference ID/Investigator# 8306

Jacksonville, Florida, 32216, United States

Location

Site Reference ID/Investigator# 8308

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 8314

Overland Park, Kansas, 66212, United States

Location

Site Reference ID/Investigator# 8307

Farmington Hills, Michigan, 48336, United States

Location

Site Reference ID/Investigator# 8318

Troy, Michigan, 48085, United States

Location

Site Reference ID/Investigator# 8309

Eugene, Oregon, 97401, United States

Location

Site Reference ID/Investigator# 8316

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 8310

Memphis, Tennessee, 38119, United States

Location

Site Reference ID/Investigator# 8319

Virginia Beach, Virginia, 23452, United States

Location

Site Reference ID/Investigator# 8305

Bellevue, Washington, 98007, United States

Location

Site Reference ID/Investigator# 8320

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

pozanicline

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Earle Bain, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

US(12)