Clinical trial NCT00554385: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-11-06
Enrollment: 283
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: ADHD-RS-IV (HV)
timeFrame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
measure: CGI-ADHD-S
timeFrame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Ref #/Investigator 6800
state: Arkansas
city: Boulder
country: United States
facility: Site Ref #/Investigator 6812
state: Colorado
city: Bradenton
country: United States
facility: Site Ref #/Investigator 8366
state: Florida
city: Jacksonville
country: United States
facility: Site Ref #/Investigator 6808
state: Florida
city: Orlando
country: United States
facility: Site Ref #/Investigator 6827
state: Florida
city: Libertyville
country: United States
facility: Site Ref #/Investigator 8383
state: Illinois
city: Northbrook
country: United States
facility: Site Ref #/Investigator 6802
state: Illinois
city: Overland Park
country: United States
facility: Site Ref #/Investigator 6824
state: Kansas
city: Troy
country: United States
facility: Site Ref #/Investigator 8428
state: Michigan
city: Omaha
country: United States
facility: Site Ref #/Investigator 6902
state: Nebraska
city: Las Vegas
country: United States
facility: Site Ref #/Investigator 6856
state: Nevada
city: Clementon
country: United States
facility: Site Ref #/Investigator 6683
state: New Jersey
city: Oklahoma City
country: United States
facility: Site Ref #/Investigator 8297
state: Oklahoma
city: Eugene
country: United States
facility: Site Ref #/Investigator 6682
state: Oregon
city: Portland
country: United States
facility: Site Ref #/Investigator 6811
state: Oregon
city: Portland
country: United States
facility: Site Ref #/Investigator 8701
state: Oregon
city: Salem
country: United States
facility: Site Ref #/Investigator 6681
state: Oregon
city: Charleston
country: United States
facility: Site Ref #/Investigator 6799
state: South Carolina
city: Memphis
country: United States
facility: Site Ref #/Investigator 7955
state: Tennessee
city: Austin
country: United States
facility: Site Ref #/Investigator 6836
state: Texas
city: Herndon
country: United States
facility: Site Ref #/Investigator 6835
state: Virginia
city: Bellevue
country: United States
facility: Site Ref #/Investigator 6791
state: Washington
city: Middleton
country: United States
facility: Site Ref #/Investigator 6838
state: Wisconsin
Study officials:
affiliation: Abbott
name: Laura Gault, M.D., Ph.D.
role: STUDY_DIRECTOR
References: