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Summary

for people ages 41–86 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities. The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy

Details

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Keywords

Supranuclear Palsy, Progressive Paralysis

Eligibility

For people ages 41–86

Key Inclusion Criteria:

  • Participants with probable or possible PSP
  • Able to ambulate independently or with assistance
  • Able to tolerate MRI
  • Have reliable caregiver to accompany participant to all study visits
  • Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening
  • Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned

Key Exclusion Criteria:

  • Presence of other significant neurological or psychiatric disorders
  • Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease
  • History of early, prominent rapid eye movement (REM) sleep behavior disorder
  • History of or screening brain MRI scan indicative of significant abnormality
  • Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • Research Site accepting new patients
    San Francisco, California, 94158, United States
  • Research Site accepting new patients
    Los Angeles, California, 90095, United States
  • Research Site accepting new patients
    Fountain Valley, California, 92708, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biogen
ID
NCT03068468
Phase
Phase 2
Lead Scientist
Adam Boxer
Study Type
Interventional
Last Updated
November 23, 2017
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