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


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


  • 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

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.