NCT00554385

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

23 active sites

Status
terminated

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

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

9 months

First QC Date

November 5, 2007

Last Update Submit

August 18, 2011

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

  • ADHD-RS-IV (HV)

    Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12

  • CGI-ADHD-S

    Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12

Study Arms (1)

1

EXPERIMENTAL
Drug: ABT-089

Interventions

ABT-089DRUG

Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.

1

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
  • If female, subject must be practicing at least one method of birth control throughout the study.
  • If female, the result of a pregnancy test is negative.
  • The subject is judged to be in generally good health.

You may not qualify if:

  • The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
  • The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
  • The subject has a positive urine drug screen for alcohol or drugs of abuse.
  • The subject anticipates a move outside the geographic area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Site Ref #/Investigator 6800

Little Rock, Arkansas, 72205, United States

Location

Site Ref #/Investigator 6812

Boulder, Colorado, 80304, United States

Location

Site Ref #/Investigator 8366

Bradenton, Florida, 34208, United States

Location

Site Ref #/Investigator 6808

Jacksonville, Florida, 32216, United States

Location

Site Ref #/Investigator 6827

Orlando, Florida, 32806, United States

Location

Site Ref #/Investigator 8383

Libertyville, Illinois, 60048, United States

Location

Site Ref #/Investigator 6802

Northbrook, Illinois, 60062, United States

Location

Site Ref #/Investigator 6824

Overland Park, Kansas, 66212, United States

Location

Site Ref #/Investigator 8428

Troy, Michigan, 48085, United States

Location

Site Ref #/Investigator 6902

Omaha, Nebraska, 68198, United States

Location

Site Ref #/Investigator 6856

Las Vegas, Nevada, 89128, United States

Location

Site Ref #/Investigator 6683

Clementon, New Jersey, 08021, United States

Location

Site Ref #/Investigator 8297

Oklahoma City, Oklahoma, 73103, United States

Location

Site Ref #/Investigator 6682

Eugene, Oregon, 97401, United States

Location

Site Ref #/Investigator 6811

Portland, Oregon, 97210, United States

Location

Site Ref #/Investigator 8701

Portland, Oregon, 97210, United States

Location

Site Ref #/Investigator 6681

Salem, Oregon, 97301, United States

Location

Site Ref #/Investigator 6799

Charleston, South Carolina, 29405, United States

Location

Site Ref #/Investigator 7955

Memphis, Tennessee, 38119, United States

Location

Site Ref #/Investigator 6836

Austin, Texas, 78756, United States

Location

Site Ref #/Investigator 6835

Herndon, Virginia, 20170, United States

Location

Site Ref #/Investigator 6791

Bellevue, Washington, 98007, United States

Location

Site Ref #/Investigator 6838

Middleton, Wisconsin, 53562, 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

  • Laura Gault, M.D., Ph.D.

    Abbott

    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

November 5, 2007

First Posted

November 6, 2007

Study Start

November 1, 2007

Primary Completion

August 1, 2008

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

US(23)