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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: ABT-089

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443391

M06-889

Details and patient eligibility

About

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

Enrollment: 141 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ABT-089