Study of BIIB092 in Participants With Progressive Supranuclear Palsy

Description

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.

Study Start Date

April, 24 2017

Estimated Completion Date

June 2020

Interventions

  • Biological: BIIB092
  • Biological: Placebo

Study ID

Biogen -- 251PP301

Status

Recruiting

Trial ID

NCT03068468

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

396

Sponsor

Biogen

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

Gender

All

Ages

41 Years to 86 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (31)

Study Location Distance Name Phone Email
Massachusetts General Hospital Cancer Center Yawkey 7E - Boston, Massachusetts 2.8 miles None None None
Mount Sinai Movement Disorders Center - New York, New York 183.2 miles Mindy Lopez Site 0081 None None
Mount Sinai Movement Disorders Center - New York, New York 183.2 miles Mindy Lopez Site 0081 None None
Mount Sinai Movement Disorders Center - New York, New York 183.2 miles Mindy Lopez Site 0081 None None
Mount Sinai Movement Disorders Center - New York, New York 183.2 miles Mindy Lopez Site 0081 None None
Mount Sinai Movement Disorders Center - New York, New York 183.2 miles Mindy Lopez Site 0081 None None
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Karen Callison Site 0016 None None
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Karen Callison Site 0016 None None
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Karen Callison Site 0016 None None
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Karen Callison Site 0016 None None
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Karen Callison Site 0016 None None
QUEST Research Institute - Farmington Hills, Michigan 625.6 miles Dolly Niles Site 0032 None None
QUEST Research Institute - Farmington Hills, Michigan 625.6 miles Dolly Niles Site 0032 None None
QUEST Research Institute - Farmington Hills, Michigan 625.6 miles Dolly Niles Site 0032 None None
QUEST Research Institute - Farmington Hills, Michigan 625.6 miles Dolly Niles Site 0032 None None
QUEST Research Institute - Farmington Hills, Michigan 625.6 miles Dolly Niles Site 0032 None None
Parkinsons Disease And Movement Disorder Center Of Boca Raton - Boca Raton, Florida 1,221.8 miles Jocelyne Fimiano Site 0012 None None
Parkinsons Disease And Movement Disorder Center Of Boca Raton - Boca Raton, Florida 1,221.8 miles Jocelyne Fimiano Site 0012 None None
Parkinsons Disease And Movement Disorder Center Of Boca Raton - Boca Raton, Florida 1,221.8 miles Jocelyne Fimiano Site 0012 None None
Parkinsons Disease And Movement Disorder Center Of Boca Raton - Boca Raton, Florida 1,221.8 miles Jocelyne Fimiano Site 0012 None None
Parkinsons Disease And Movement Disorder Center Of Boca Raton - Boca Raton, Florida 1,221.8 miles Jocelyne Fimiano Site 0012 None None
The University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles None None None
Banner Sun Health Research Institute - Sun City, Arizona 2,304.3 miles None None None
Swedish Health Services - Seattle, Washington 2,488.3 miles None None None
The Parkinsons and Movement Disorder Institute - Fountain Valley, California 2,590.7 miles Evan MorenoDavis Site 0018 None None
The Parkinsons and Movement Disorder Institute - Fountain Valley, California 2,590.7 miles Evan MorenoDavis Site 0018 None None
The Parkinsons and Movement Disorder Institute - Fountain Valley, California 2,590.7 miles Evan MorenoDavis Site 0018 None None
The Parkinsons and Movement Disorder Institute - Fountain Valley, California 2,590.7 miles Evan MorenoDavis Site 0018 None None
The Parkinsons and Movement Disorder Institute - Fountain Valley, California 2,590.7 miles Evan MorenoDavis Site 0018 None None
UCLA - Los Angeles, California 2,605.2 miles None None None
UCSF Memory and Aging Center - San Francisco, California 2,696.4 miles None None None

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