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

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

This study has been terminated.

Study NCT00554385. Last updated on September 11, 2008. Information provided by Abbott

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Attention-Deficit/Hyperactivity Disorder

Intervention ^†

Drug: ABT-089

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

283

Start Date ^†

November 2007

Completion Date

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00554385

Organization ID

M10-178

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

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

Abbott

Information Provided By

Abbott

Verification Date

September 2008

First Received Date ^†

November 5, 2007

Last Updated Date

September 11, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.