Study of BIIB092 in Participants With Progressive Supranuclear Palsy

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Brief Title

Study of BIIB092 in Participants With Progressive Supranuclear Palsy

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

Brief 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.
    

Detailed Description

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

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52

Secondary Outcome

 Change From Baseline in Movement Disorder Society (MDS)-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52

Condition

Supranuclear Palsy, Progressive

Intervention

BIIB092

Study Arms / Comparison Groups

 BIIB092
Description:  Participants will receive BIIB092 50 mg/ml intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

490

Start Date

June 1, 2017

Completion Date

February 7, 2020

Primary Completion Date

September 6, 2019

Eligibility Criteria

        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 - 86 Years

Accepts Healthy Volunteers

No

Contacts

Medical Director, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03068468

Organization ID

251PP301

Secondary IDs

2016-002554-21

Responsible Party

Sponsor

Study Sponsor

Biogen


Study Sponsor

Medical Director, Study Director, Biogen


Verification Date

November 2020