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

Overview

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

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy”

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

Arms, Groups and Cohorts

  • Placebo Comparator: Group 3
    • Placebo for ABBV-8E12
  • Experimental: Group 1
    • Dose 1 ABBV-8E12
  • Experimental: Group 2
    • Dose 2 ABBV-8E12

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score
    • Time Frame: Baseline, Week 52
    • The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).
  • Adverse Events
    • Time Frame: 68 weeks

Secondary Measures

  • Time to Cmax (Tmax) for ABBV-8E12
    • Time Frame: 16 weeks
  • Change from Baseline to Week 52 in Clinical Global Impression of Change (CGI-C)
    • Time Frame: Baseline, Week 52
    • The CGI-C is a clinician’s rating of improvement in disease severity.
  • Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
    • Time Frame: Baseline, Week 52
    • Midbrain atrophy as measured by change in volumetric MRI from baseline to Week 52.
  • Area under the concentration time curve (AUC) for ABBV-8E12
    • Time Frame: 16 weeks
  • Maximum observed serum concentration (Cmax) for ABBV-8E12
    • Time Frame: 16 weeks
  • Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12
    • Time Frame: 52 weeks
  • Change from Baseline to Week 52 in Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
    • Time Frame: Baseline, Week 52
    • The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson’s disease.
  • Change from Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)
    • Time Frame: Baseline, Week 52
    • The SEADL assesses the subject’s ability to perform daily activities.

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female subject with age 40 years or greater at the time of signed consent. – Meets the criteria for possible or probable progressive supranuclear palsy (Steele-Richardson-Olszewski Syndrome). – Presence of PSP symptoms for less than 5 years. – Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker). – 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 screening. – MMSE score less than 15 at screening. – Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI). – Subject 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 subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria. – Subject has had a significant illness or infection requiring medical intervention in the past 30 days.
  • 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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