Attention-Deficit/Hyperactivity Disorder
Conditions
Brief summary
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.
Interventions
DRUGABT-089
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD-RS-IV (HV) | Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 |
| CGI-ADHD-S | Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 |
Countries
United States
Outcome results
None listed