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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00640419
First received: March 18, 2008
Last updated: January 10, 2013
Last verified: January 2013

March 18, 2008
January 10, 2013
March 2008
July 2008   (final data collection date for primary outcome measure)
ADHD-RS-IV (HV) [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 ] [ Designated as safety issue: No ]
  • ADHD-RS-IV (HV) [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28 Day 42 ] [ Designated as safety issue: No ]
  • CGI-ADHD-S [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28 Day 42 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00640419 on ClinicalTrials.gov Archive Site
  • CSHQ [ Time Frame: Day-1, Day 28, Day 42 ] [ Designated as safety issue: No ]
  • CGI-P [ Time Frame: Day -1, Day 21, Day 42 ] [ Designated as safety issue: No ]
  • BRIEF [ Time Frame: Day -1, Day 28, Day 42 ] [ Designated as safety issue: No ]
  • CGI-ADHD-S [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28 and Day 42 ] [ Designated as safety issue: No ]
  • CSHQ [ Time Frame: Day-1, Day 28, Day 42 ] [ Designated as safety issue: No ]
  • CGI-P [ Time Frame: Day -1, Day 21, Day 42 ] [ Designated as safety issue: No ]
  • BRIEF [ Time Frame: Day -1, Day 28, Day 42 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
  • Drug: ABT-089
    Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
  • Drug: 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.
  • Experimental: 1
    Intervention: Drug: ABT-089
  • Experimental: 2
    Intervention: Drug: ABT-089
  • Placebo Comparator: 3
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00640419
M10-345
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Laura Gault AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP