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

Phase 2

Terminated

• Conditions: Attention-Deficit/Hyperactivity Disorder
• Interventions: Drug: ABT-089

• Registration Number: NCT00554385
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2008-08
• Status Verified: 2011-08
• Disposition First Submitted: 2011-08-18
• Disposition First Submitted QC: 2011-08-18
• Last Update Submitted: 2011-08-18
• Disposition First Posted: 2011-08-23
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 283

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ABT-089	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (23)

Site Ref #/Investigator 8366; 🇺🇸 Bradenton, Florida, United States

Site Ref #/Investigator 6808; 🇺🇸 Jacksonville, Florida, United States

Site Ref #/Investigator 6824; 🇺🇸 Overland Park, Kansas, United States

Site Ref #/Investigator 6812; 🇺🇸 Boulder, Colorado, United States

Site Ref #/Investigator 8383; 🇺🇸 Libertyville, Illinois, United States

Site Ref #/Investigator 6902; 🇺🇸 Omaha, Nebraska, United States

Site Ref #/Investigator 6856; 🇺🇸 Las Vegas, Nevada, United States

Site Ref #/Investigator 8701; 🇺🇸 Portland, Oregon, United States

Site Ref #/Investigator 6799; 🇺🇸 Charleston, South Carolina, United States

Site Ref #/Investigator 6836; 🇺🇸 Austin, Texas, United States

Site Ref #/Investigator 8297; 🇺🇸 Oklahoma City, Oklahoma, United States

Site Ref #/Investigator 6835; 🇺🇸 Herndon, Virginia, United States

Site Ref #/Investigator 6811; 🇺🇸 Portland, Oregon, United States

Site Ref #/Investigator 6838; 🇺🇸 Middleton, Wisconsin, United States

Site Ref #/Investigator 6681; 🇺🇸 Salem, Oregon, United States

Site Ref #/Investigator 8428; 🇺🇸 Troy, Michigan, United States

Site Ref #/Investigator 6802; 🇺🇸 Northbrook, Illinois, United States

Site Ref #/Investigator 6800; 🇺🇸 Little Rock, Arkansas, United States

Site Ref #/Investigator 6827; 🇺🇸 Orlando, Florida, United States

Site Ref #/Investigator 6683; 🇺🇸 Clementon, New Jersey, United States

Site Ref #/Investigator 6682; 🇺🇸 Eugene, Oregon, United States

Site Ref #/Investigator 7955; 🇺🇸 Memphis, Tennessee, United States

Site Ref #/Investigator 6791; 🇺🇸 Bellevue, Washington, United States