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

NCT00640419 | Completed Phase 2 DMC

• 1 other identifier: M10-345
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• ADHD-RS-IV (HV)

  Screening, Day -1, Day 7, Day 14, Day 28, Day 42

Secondary Outcomes (4)

• CSHQ

  Day-1, Day 28, Day 42

• CGI-P

  Day -1, Day 21, Day 42

• BRIEF

  Day -1, Day 28, Day 42

• CGI-ADHD-S

  Screening, Day -1, Day 7, Day 14, Day 28 and Day 42

Study Arms (3)

1

EXPERIMENTAL

Drug: ABT-089

2

EXPERIMENTAL

Drug: ABT-089

3

PLACEBO COMPARATOR

Drug: placebo

Interventions

ABT-089 DRUG

Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.

1; 2

placebo DRUG

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.

3

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (13)

Site Reference ID/Investigator# 7536

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 7954

Bradenton, Florida, 34208, United States

Location

Site Reference ID/Investigator# 7543

Jacksonville, Florida, 32216, United States

Location

Site Reference ID/Investigator# 7542

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 7537

Libertyville, Illinois, 60048, United States

Location

Site Reference ID/Investigator# 7561

Overland Park, Kansas, 66212, United States

Location

Site Reference ID/Investigator# 7560

Troy, Michigan, 48085, United States

Location

Site Reference ID/Investigator# 7559

Omaha, Nebraska, 68198, United States

Location

Site Reference ID/Investigator# 7541

Las Vegas, Nevada, 89128, United States

Location

Site Reference ID/Investigator# 7564

Oklahoma City, Oklahoma, 73103, United States

Location

Site Reference ID/Investigator# 7538

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 7540

Memphis, Tennessee, 38119, United States

Location

Site Reference ID/Investigator# 7544

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

• Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25.

  PMID: 21156272 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

pozanicline

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Laura Gault

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

US (13)