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COMPLETEDPHASE2

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of 0.7 mg/kg/Day and 1.4 mg/kg/Day of ABT-089 in the Treatment of Children With Attention Deficit-Hyperactivity Disorder (ADHD)

NCT00640419•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

Summary

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).

Eligibility

Age

6 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have voluntarily signed an informed consent form.
•Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s).
•Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
•Subject weights at least 37 pounds (17 kg)
•Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
•Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria

•Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
•Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind.
•Subject has a history of, or ongoing, serious medical problem.
•Subject has a history of significant allergic reaction to any drug.
•Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
•Subject requires ongoing treatment with any psychiatric medication.

Locations (13)

Site Reference ID/Investigator# 7536

Little Rock, Arkansas, United States

Site Reference ID/Investigator# 7954

Bradenton, Florida, United States

Site Reference ID/Investigator# 7543

Jacksonville, Florida, United States

Site Reference ID/Investigator# 7542

Orlando, Florida, United States

Site Reference ID/Investigator# 7537

Libertyville, Illinois, United States

Site Reference ID/Investigator# 7561

Overland Park, Kansas, United States

Site Reference ID/Investigator# 7560

Troy, Michigan, United States

Site Reference ID/Investigator# 7559

Omaha, Nebraska, United States

Site Reference ID/Investigator# 7541

Las Vegas, Nevada, United States

Site Reference ID/Investigator# 7564

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

March 1, 2008

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

January 18, 2013

Enrollment

121

ACTUAL participants

Conditions

Attention-Deficit/Hyperactivity Disorder

Interventions

ABT-089

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening

The ADHD Kids´ Study for Children 9-12 Years of Age

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Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder

A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD