Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Attention-Deficit/Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686933
• Other study ID #: M10-425
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2008
• Last updated: January 11, 2013
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• ABT-089
Subjects will take up to 80 mg daily for 24 months

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 8305	Bellevue	Washington
United States	Site Reference ID/Investigator# 8309	Eugene	Oregon
United States	Site Reference ID/Investigator# 8307	Farmington Hills	Michigan
United States	Site Reference ID/Investigator# 8306	Jacksonville	Florida
United States	Site Reference ID/Investigator# 8315	Lafayette	California
United States	Site Reference ID/Investigator# 8310	Memphis	Tennessee
United States	Site Reference ID/Investigator# 8308	Orlando	Florida
United States	Site Reference ID/Investigator# 8314	Overland Park	Kansas
United States	Site Reference ID/Investigator# 8316	Portland	Oregon
United States	Site Reference ID/Investigator# 8320	Seattle	Washington
United States	Site Reference ID/Investigator# 8318	Troy	Michigan
United States	Site Reference ID/Investigator# 8319	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAARS:Inv		Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24	No
Primary	CGI-ADHD-S		Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	CAARS:Self		Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	BRIEF-A		Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	AAQOL		Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	WPAI		Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	FTND		Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24	No