Safety, Tolerability and Efficacy Study of ABT-089 in Adults 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:
NCT00640185
First received: March 18, 2008
Last updated: January 10, 2013
Last verified: January 2013

March 18, 2008
January 10, 2013
March 2008
August 2008   (final data collection date for primary outcome measure)
CAARS: Inv Total Score [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
  • CAARS: Inv [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
  • CGI-ADHD-S [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
  • AISRS [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00640185 on ClinicalTrials.gov Archive Site
  • CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
  • TASS, AAQoL, WPAI [ Time Frame: Day -1, Day 28, Day 56 ] [ Designated as safety issue: No ]
  • BRIEF-A, FTND [ Time Frame: Day-1, Day 56 ] [ Designated as safety issue: No ]
  • QSU-Brief, Number of Cigarettes smoked per day [ Time Frame: Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 ] [ Designated as safety issue: No ]
  • CAARS: Self [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
  • TASS [ Time Frame: Day -1, Day 28, Day 56 ] [ Designated as safety issue: No ]
  • BRIEF-A [ Time Frame: Day-1, Day 56 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults 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 adults 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)
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
  • Drug: ABT-089
    Subjects will take up to two 40 mg tablets once daily for 8 weeks.
  • Drug: Placebo
    Subjects will take one or two placebos once daily for the duration of the study.
  • Placebo Comparator: 1
    Interventions:
    • Drug: ABT-089
    • Drug: Placebo
  • Experimental: 2
    Interventions:
    • Drug: ABT-089
    • Drug: Placebo
  • Experimental: 3
    Interventions:
    • Drug: ABT-089
    • Drug: Placebo
Bain EE, Apostol G, Sangal RB, Robieson WZ, McNeill DL, Abi-Saab WM, Saltarelli MD. A randomized pilot study of the efficacy and safety of ABT-089, a novel α4β2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jun;73(6):783-9. doi: 10.4088/JCP.10m06719.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
August 2008
August 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 subject.
  • Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
  • 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.
  • Male subjects must agree to comply with applicable contraceptive requirements.
  • Subject is 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 schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
  • Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep 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
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00640185
M10-346
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Earle Bain AbbVie
AbbVie
January 2013

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