Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03068468 |
Date of registration:
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27/02/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of BIIB092 in Participants With Progressive Supranuclear Palsy
PASSPORT |
Scientific title:
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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 |
Date of first enrolment:
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June 1, 2017 |
Target sample size:
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490 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03068468 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Austria
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Canada
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France
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Germany
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Greece
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Italy
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Japan
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Korea, Republic of
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Russian Federation
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Medical Director |
Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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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
Age minimum:
41 Years
Age maximum:
86 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Supranuclear Palsy, Progressive
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Intervention(s)
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Drug: BIIB092
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Drug: Placebo
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Primary Outcome(s)
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Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52
[Time Frame: Baseline, Week 52]
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Percentage of Participants with Death, Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation, and Grade 3 and 4 Laboratory Abnormalities
[Time Frame: Up to 52 Weeks]
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Secondary Outcome(s)
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Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52
[Time Frame: Baseline, Week 52]
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Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48
[Time Frame: Baseline, Week 48]
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Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52
[Time Frame: Baseline, Week 52]
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Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score
[Time Frame: Baseline, Week 52]
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Clinical Global Impression of Change (CGI-C) Scale Score
[Time Frame: Week 52]
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Change From Baseline in Letter-Number Sequencing Test at Week 48
[Time Frame: Baseline, Week 48]
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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
[Time Frame: Baseline, Week 52]
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Change From Baseline in Phonemic Fluency Test Score at Week 48
[Time Frame: Baseline, Week 48]
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Percent Change from Baseline of Brain Volumes as Determined by MRI
[Time Frame: Up to Week 52]
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Change From Baseline in Color Trails Test at Week 48
[Time Frame: Baseline, Week 48]
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Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48
[Time Frame: Baseline, Week 48]
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Number of Participants with Drug Antibodies (anti-BIIB092) in Serum
[Time Frame: Up to Week 52]
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Secondary ID(s)
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2016-002554-21
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251PP301
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CN002-012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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