Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 20, 2019

Interventions

  • Drug: ABBV-8E12
    • Solution for infusion

Arms, Groups and Cohorts

  • Experimental: ABBV-8E12
    • ABBV-8E12 administered by intravenous (IV) infusion.

Clinical Trial Outcome Measures

Primary Measures

  • Adverse Events
    • Time Frame: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)
    • Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject completed Study C2N-8E12-WW-104 (NCT02494024) – Subject was not eligible to enroll in Study M15-562 (NCT02985879) Exclusion Criteria:
  • Subject weighs less than 35 kg at screening – Subject has any contraindication or inability to tolerate brain 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
  • Gender Eligibility: All

    Minimum Age: 18 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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