Clinical Trial: A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome:

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
• Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
• Area under the concentration time curve (AUC) 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 in PSP-RS Total Score from Baseline to Each Observation [ Time Frame: 52 weeks ]
  The PSP-RS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).
• Change in Schwab and England Activities of Daily Living Scale (SEADL) [ Time Frame: 52 weeks ]
  The SEADL assesses the subject's ability to perform daily activities.
• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [ Time Frame: 52 weeks ]
  The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.
• Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: 52 weeks ]
  The CGI-S is a clinician's rating of disease severity.
• Change in Clinical Global Impression of Change (CGI-C) [ Time Frame: 52 weeks ]
  The CGI-C is a clinician's rating of improvement in disease severity.
• Change in Progressive Supranuclear Palsy Quality of Life (PSP-QoL) Subscale Scores and Visual Analog Scale (VAS) [ Time Frame: 52 weeks ]
  The PSP-QoL is a validated patient-reported outcome measure to assess quality of life of patients with PSP.

Original Secondary Outcome:

• Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
• Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
• Area under the concentration time curve (AUC) 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 in PSP-RS Total Score from Baseline to Each Observation [ Time Frame: 52 weeks ]
  The PSP-RS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).
• Change in Schwab and England Activities of Daily Living Scale (SEADL) [ Time Frame: 52 weeks ]
  The SEADL assesses the subject's ability to perform daily activities.
• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) [ Time Frame: 52 weeks ]
  The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.
• Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: 52 weeks ]
  The CGI-S is a clinician's rating of disease severity.
• Change in Clinical Global Impression of Change (CGI-C) [ Time Frame: 52 weeks ]
  The CGI-C is a clinician's rating of improvement in disease severity.
• Change in Progressive Supranuclear Palsy Quality of Life (PSP-QoL) [ Time Frame: 52 weeks ]
  The PSP-QoL is a validated patient-reported outcome measure to assess quality of life of patients with PSP.

Information By: AbbVie

Dates:
Date Received: December 1, 2016
Date Started: December 16, 2016
Date Completion: September 8, 2019
Last Updated: April 14, 2017
Last Verified: April 2017