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

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640419
• Other study ID #: M10-345
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2008
• Last updated: January 10, 2013
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• ABT-089
Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
• placebo
Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 7544	Bellevue	Washington
United States	Site Reference ID/Investigator# 7954	Bradenton	Florida
United States	Site Reference ID/Investigator# 7543	Jacksonville	Florida
United States	Site Reference ID/Investigator# 7541	Las Vegas	Nevada
United States	Site Reference ID/Investigator# 7537	Libertyville	Illinois
United States	Site Reference ID/Investigator# 7536	Little Rock	Arkansas
United States	Site Reference ID/Investigator# 7540	Memphis	Tennessee
United States	Site Reference ID/Investigator# 7564	Oklahoma City	Oklahoma
United States	Site Reference ID/Investigator# 7559	Omaha	Nebraska
United States	Site Reference ID/Investigator# 7542	Orlando	Florida
United States	Site Reference ID/Investigator# 7561	Overland Park	Kansas
United States	Site Reference ID/Investigator# 7538	Portland	Oregon
United States	Site Reference ID/Investigator# 7560	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-RS-IV (HV)		Screening, Day -1, Day 7, Day 14, Day 28, Day 42	No
Secondary	CSHQ		Day-1, Day 28, Day 42	No
Secondary	CGI-P		Day -1, Day 21, Day 42	No
Secondary	BRIEF		Day -1, Day 28, Day 42	No
Secondary	CGI-ADHD-S		Screening, Day -1, Day 7, Day 14, Day 28 and Day 42	No