Long Term 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

NCT00686933

M10-425

Details and patient eligibility

About

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).

Enrollment: 117 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ABT-089