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

Abbott

Status and phase: Terminated; Phase 2

Conditions: Attention-Deficit/Hyperactivity Disorder

Treatments: Drug: ABT-089

Study type: Interventional

Funder types: Industry

Identifiers

NCT00554385

M10-178

Details and patient eligibility

About

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

Enrollment: 283 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
• If female, subject must be practicing at least one method of birth control throughout the study.
• If female, the result of a pregnancy test is negative.
• The subject is judged to be in generally good health.

Exclusion criteria

• The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
• The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
• The subject has a positive urine drug screen for alcohol or drugs of abuse.
• 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)

---

283 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ABT-089