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

Tracking Information

First Received Date ^ICMJE

November 5, 2007

Last Updated Date

September 11, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ADHD-RS-IV (HV) [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]
CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

ADHD-RS-IV (HV) [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ]
CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ]

Change History

Complete list of historical versions of study NCT00554385 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Long-Term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Attention-Deficit/Hyperactivity Disorder

Intervention ^ICMJE

Drug: ABT-089

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

283

Completion Date

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Years to 13 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00554385

Responsible Party

Laura Gault, M.D., PhD Study Director, Abbott

Study ID Numbers ^ICMJE

M10-178

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Laura Gault, M.D., Ph.D.

Abbott

Information Provided By

Abbott

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP