An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

Study Identifier
M15-563
CT.gov Identifier
NCT03391765
EudraCT Identifier
2017-001590-16
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, Italian
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Study Details

Medical Condition
  • Movement Disorders - Other
    • Study Drug
  • ABBV-8E12
  • Placebo solution for IV infusion on Day 15
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    40+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant completed the 52-week treatment period in Study M15-562 (NCT02985879) * In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879) * 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 the time of study entry * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI) * Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results * More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879) * Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations

    Protocol Summary

    The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).

    Study Locations

    Location
    Status
    Location
    Univ Alabama-Birmingham /ID# 165522
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    Mayo Clinic Arizona /ID# 165521
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    Cedars-Sinai Medical Center /ID# 165567
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Usc /Id# 165529
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    University of California, Los Angeles /ID# 165669
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    University of California, San /ID# 165560
    San Diego, California, United States, 92037
    Status
    Not applicable
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