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

Study Identifier
M10-346
CT.gov Identifier
NCT00640185
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Attention-Deficit/Hyperactivity Disorder (ADHD)
    • Study Drug
  • ABT-089
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 60 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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).

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 7546
    Lafayette, California, United States, 94549
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 7551
    Jacksonville, Florida, United States, 32216
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 7553
    Orlando, Florida, United States, 32806
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 7545
    Overland Park, Kansas, United States, 66212
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 7552
    Farmington Hills, Michigan, United States, 48336
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 7548
    Troy, Michigan, United States, 48085
    Status
    Not applicable
    Showing {first} - {last} of {total} Results