Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
NCT ID: NCT02157714
Last Updated: 2016-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PRX002
PRX002
PRX002
Placebo
Placebo
Placebo
Interventions
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PRX002
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs
* Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
* Male subjects and their partners of childbearing potential must use contraception
Exclusion Criteria
* Abnormal MRI
* Significant laboratory abnormalities
40 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Prothena Biosciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Soto
Role: STUDY_DIRECTOR
Clinical Trials Prothena Biosciences Inc
Locations
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Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
MD Clinical
Hallandale, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
QUEST Research Institute
Bingham Farms, Michigan, United States
Oregon Health and Science University, Department of Neurology
Portland, Oregon, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487.
Schenk DB, Koller M, Ness DK, Griffith SG, Grundman M, Zago W, Soto J, Atiee G, Ostrowitzki S, Kinney GG. First-in-human assessment of PRX002, an anti-alpha-synuclein monoclonal antibody, in healthy volunteers. Mov Disord. 2017 Feb;32(2):211-218. doi: 10.1002/mds.26878. Epub 2016 Nov 25.
Other Identifiers
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PRX002-CL002
Identifier Type: -
Identifier Source: org_study_id
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