Progressive Supranuclear Palsy Trial of BMS-986168

  • Study Director: Adam Boxer, MD, PhD
  • Sponsor: Bristol Myers Squibb
  • Recruiting? Yes
  • Official Study Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BMS-986168 in Participants with Progressive Supranuclear Palsy
  • ClinicalTrials.gov Identifier: NCT03068468
  • Conditions Studied: Progressive supranuclear palsy (PSP)
  • Intervention: BMS-986168 and placebo control; BMS-986168 is administered intravenously (IV) once every four weeks
  • Phase: Phase 2

Purpose of the Study

The primary purpose of this study is to find out whether BMS-986168 has the potential to slow disease progression in subjects with progressive supranuclear palsy (PSP) by comparing it to placebo and to characterize its safety/tolerability profile.

Eligibility

Inclusion Criteria: Subjects must have probable or possible PSP with age of symptom onset of 40 to 85 years and current age between 41–86 years. Subjects must also have a Mini Mental State Examination (MMSE) score of 20 through 30 inclusive at the screening visit. Subjects must be able to ambulate indepently or walk with assistance, and must have PSP symptoms for less than or equal to five years at screening. Subjects must be willing and able to have brain MRIs. Subjects must have a reliable informant or caregiver who is willing to complete study-related questionnaires.

Exclusion Criteria: Subjects must not meet diagnostic criteria for another medical or neurological condition (other than progressive supranuclear palsy) that might be a contributing cause of the subject’s impairment. Subject must also not have a history of REM sleep behavior disorder, known history of abnormal serum or plasma progranulin levels, history of deep brain stimulator surgery, HIV infection, Hepatitis C or B infection, and any contraindications to MRI scans. Subjects must not be currently enrolled in another clinical trial.

What to Expect

Testing: Monthly infusions, multiple brain MRIs, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, vital signs

The Frequency of Visits:

  • Screening phase: Two visits within 42 days of the first infusion
  • Dose administration in placebo-controlled period: Monthly infusions for 52 weeks
  • Dose administration in open-label extension period: Monthly infusions for at least 100 weeks
  • Follow-up safety visits: 30 days

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), with age at symptom onset of 40 to 85 years, current age between 41 and 86 years at the time of screening, and presence of PSP symptoms for less than or equal to five years.

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 $75 for each scheduled visit to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Avery O’HaraAvery.OHara@ucsf.edu, 415.476.8333
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRCMary.Koestler@ucsf.edu, 415.476.0661