Clinical trial NCT00686933: Long Term 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 for Subjects Completing Study M10-346
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 117
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 effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).


Eligibility criteria: Inclusion Criteria:

* The subject was randomized into Study M10-346 and completed the study.
* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Male subjects must agree to comply with applicable contraceptive requirements.
* The subject is judged to be in generally good health.

Exclusion Criteria:

* The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 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, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
measure: CGI-ADHD-S
timeFrame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Secondary outcomes:
measure: CAARS:Self
timeFrame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
measure: BRIEF-A
timeFrame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
measure: AAQOL
timeFrame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
measure: WPAI
timeFrame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
measure: FTND
timeFrame: Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Site Reference ID/Investigator# 8315
state: California
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 8306
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 8308
state: Florida
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 8314
state: Kansas
city: Farmington Hills
country: United States
facility: Site Reference ID/Investigator# 8307
state: Michigan
city: Troy
country: United States
facility: Site Reference ID/Investigator# 8318
state: Michigan
city: Eugene
country: United States
facility: Site Reference ID/Investigator# 8309
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 8316
state: Oregon
city: Memphis
country: United States
facility: Site Reference ID/Investigator# 8310
state: Tennessee
city: Virginia Beach
country: United States
facility: Site Reference ID/Investigator# 8319
state: Virginia
city: Bellevue
country: United States
facility: Site Reference ID/Investigator# 8305
state: Washington
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 8320
state: Washington
Study officials:
affiliation: AbbVie
name: Earle Bain, MD
role: STUDY_DIRECTOR
References: