Clinical trial NCT00443391: A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)
Official title: The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
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 adults with ADHD.


Eligibility criteria: Inclusion Criteria:

* The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
* If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
* If female, the result of a pregnancy tests are negative
* The subject is judged to be in generally good health

Exclusion Criteria:

* More than 7 days have elapsed since the last dose of study drug in Study M06-855
* The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
* The subject anticipates a move outside the geographic area

Primary outcomes:
measure: CAARS:INV
timeFrame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
measure: CGI-ADHD-S
timeFrame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Secondary outcomes:
measure: AAQoL
timeFrame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
measure: WPAI
timeFrame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
measure: RUQ
timeFrame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
measure: FTND
timeFrame: Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Site Reference ID/Investigator# 6109
state: Arizona
city: Mesa
country: United States
facility: Site Reference ID/Investigator# 6765
state: Arizona
city: Lafayette
country: United States
facility: Site Reference ID/Investigator# 6100
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 6107
state: California
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 6112
state: Florida
city: Maitland
country: United States
facility: Site Reference ID/Investigator# 6096
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 6105
state: Florida
city: Smyrna
country: United States
facility: Site Reference ID/Investigator# 6094
state: Georgia
city: Newton
country: United States
facility: Site Reference ID/Investigator# 6111
state: Kansas
city: Farmington Hills
country: United States
facility: Site Reference ID/Investigator# 6113
state: Michigan
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 6110
state: Nebraska
city: New York
country: United States
facility: Site Reference ID/Investigator# 6099
state: New York
city: Chapel Hill
country: United States
facility: Site Reference ID/Investigator# 6106
state: North Carolina
city: Portland
country: United States
facility: Site Reference ID/Investigator# 6102
state: Oregon
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 6097
state: South Carolina
city: Memphis
country: United States
facility: Site Reference ID/Investigator# 6098
state: Tennessee
city: Austin
country: United States
facility: Site Reference ID/Investigator# 6103
state: Texas
city: Lake Jackson
country: United States
facility: Site Reference ID/Investigator# 6104
state: Texas
city: Herndon
country: United States
facility: Site Reference ID/Investigator# 6095
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 6092
state: Washington
city: Middleton
country: United States
facility: Site Reference ID/Investigator# 6101
state: Wisconsin
Study officials:
affiliation: AbbVie
name: Laura Gault, MD, PhD, MD
role: STUDY_DIRECTOR
References: