A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

Study Identifier
M15-562
CT.gov Identifier
NCT02985879
EudraCT Identifier
2016-001635-12
EUCTIS ID
Not available
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Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, French, German, Italian, Japanese, Spanish
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Study Details

Medical Condition
  • Neuroscience - Other
    • Study Drug
  • Placebo
  • ABBV-8E12
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    40+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female participant with age 40 years or greater at the time of signed consent * Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome) * Presence of PSP symptoms for less than 5 years * Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker) * Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)
    Exclusion Criteria:
    * Participants who weigh less than 44 kg (97 lbs) at screening * Mini-Mental State Examination (MMSE) score less than 15 at screening * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI) * Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period * Evidence of any clinically significant neurological disorder other than PSP * The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria * Participant has had a significant illness or infection requiring medical intervention in the past 30 days

    Protocol Summary

    The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 144892
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Mayo Clinic - Scottsdale /ID# 144893
    Scottsdale, Arizona, United States, 85259
    Status
    Not applicable
    Location
    Cedars-Sinai Medical Center /ID# 149775
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Ucsd /Id# 144905
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Usc /Id# 149773
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    University of California, Los Angeles /ID# 144896
    Los Angeles, California, United States, 90095
    Status
    Not applicable
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