Progressive Supranuclear Palsy Trial of ABBV-8E12

  • Study Director: Richard Tsai, MD
  • Sponsor: AbbVie
  • Recruiting? Yes
  • Official Study Title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
  • ClinicalTrials.gov Identifier: NCT02985879
  • Conditions Studied: Progressive supranuclear palsy (PSP)
  • Intervention: Two arms of ABBV-8E12 and placebo control. This trial consists of infusions given intravenously (IV) over a 52-week duration.
  • Phase: Phase 2

Purpose of the Study

The purpose of this study is to evaluate the efficacy and safety of ABBV-8E12 in patients with progressive supranuclear palsy (PSP).

Eligibility

Inclusion Criteria: Participants must be 40 years or greater, meet criteria for PSP and have a reliable study partner who can accurately report the participant’s behavior and is able to accompany them to study visits. Participants must be on stable doses of all allowable medications 30 days prior to screening. Participants must be willing and able to have MRIs throughout the course of the study as well as lumbar punctures. Participants must also have a Mini Mental state Examination (MMSE) score between 15–30 at the time of screening. Participants should also be able to walk five steps with minimal assistance and have had a presence of PSP symptoms for less than 5 years. All participants must have a reliable study partner who has frequent contact with the patient and can accompany the participant to study visits. All female participants should not be pregnant or breastfeeding during the study.

Exclusion Criteria: Participants must not weigh less than 44kg (97lbs) at screening. Participants cannot reside in a skilled nursing facility or dementia care facility. Participant must not have any disorder that could explain the signs of PSP or is clinically significant. Participants must not have a history of schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or any uncontrolled psychiatric illness. Participants must not have significant illness or infection requiring medical intervention within 30 days prior to screening. The participant cannot receive an investigational product within a time period equal to five half-lives or within six weeks (for small molecules) or six months (for monoclonal antibodies or other biologics) prior to study administration.

What to Expect

Testing: Monthly infusions, neurological and physical examinations, MRIs, lumbar punctures, cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection and vital signs

The Frequency of Visits:

  • Screening phase: 2–3 visits within 8 weeks of the first infusion
  • Dose administration in placebo-controlled period: Monthly infusions for 52 weeks
  • Follow up visits after dose administration period: Two visits within 20 weeks
  • Dose administration in open-label extension period: TBD

Materials Needed Before Evaluation: Participants meet criteria for probable or possible PSP (based on the National Institute of Neurological Disorders & Stroke and The Society for Progressive Supranuclear Palsy).

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and participants will be reimbursed up to $100 for each scheduled visit to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Megan FrankMegan.Frank@ucsf.edu, 415.476.0671
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRCMary.Koestler@ucsf.edu, 415.476.0661