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

Overview

The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). In a subset of participants at participating sites, participants will be assigned digital sensor BioStamp to assess body position and gait.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 20, 2019

Interventions

  • Drug: ABBV-8E12
    • ABBV-8E12 solution for IV infusion

Arms, Groups and Cohorts

  • Experimental: Group 2
    • Dose 2 ABBV-8E12
  • Experimental: Group 1
    • Dose 1 ABBV-8E12

Clinical Trial Outcome Measures

Primary Measures

  • Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years
    • Time Frame: Up to approximately 5 years
    • The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).

Secondary Measures

  • Change in Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
    • Time Frame: Up to approximately 5 years
    • The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson’s disease.
  • Change in Clinical Global Impression of Change (CGI-C)
    • Time Frame: Up to approximately 5 years
    • The CGI-C is a clinician’s rating of change in disease severity.
  • Change in Schwab and England Activities of Daily Living Scale (SEADL)
    • Time Frame: Up to approximately 5 years
    • The SEADL assesses the subject’s ability to perform daily activities.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject completed the 52-week treatment period in Study M15-562 (NCT02985879). – In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879). – Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend). Exclusion Criteria:
  • Subjects 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). – Subject 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 subject received his/her last dose of study drug in Study M15-562 (NCT02985879). – Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.
  • Gender Eligibility: All

    Minimum Age: 40 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • AbbVie
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • AbbVie Inc., Study Director, AbbVie

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