Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease
1 other identifier
interventional
64
1 country
8
Brief Summary
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedOctober 21, 2016
October 1, 2016
2.3 years
June 4, 2014
October 19, 2016
Conditions
Outcome Measures
Primary Outcomes (12)
Safety and tolerability as determined by number of subjects with adverse events
up to 6 months
Determination of pharmacokinetics parameters
maximum concentration (Cmax)
up to 6 months
Determination of pharmacokinetics parameters
time of the maximum measured concentration (Tmax)
up to 6 months
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
up to 6 months
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
up to 6 months
Determination of pharmacokinetics parameters
elimination rate constant
up to 6 months
Determination of pharmacokinetics parameters
terminal elimination half life (t½)
up to 6 months
Determination of pharmacokinetics parameters
clearance (CL)
up to 6 months
Determination of pharmacokinetics parameters
apparent volume of distribution (Vd)
up to 6 months
Determination of pharmacokinetics parameters
average concentration over a dosing interval (Cav)
up to 6 months
Determination of pharmacokinetics parameters
area under the plasma concentration-time curve for a dosing interval (AUCtau)
up to 6 months
Determination of pharmacokinetics parameters
minimum observed concentration (Cmin)
up to 6 months
Secondary Outcomes (1)
Immunogenicity as determined by measurement of anti-PRX002 antibodies
up to 3 months
Study Arms (2)
PRX002
EXPERIMENTALPRX002
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's disease, Hoehn and Yahr 1-3
- 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
You may not qualify if:
- Significant cardiac history
- Abnormal MRI
- Significant laboratory abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prothena Biosciences Limitedlead
- Hoffmann-La Rochecollaborator
Study Sites (8)
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
MD Clinical
Hallandale, Florida, 33009, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
QUEST Research Institute
Bingham Farms, Michigan, 48025, United States
Oregon Health and Science University, Department of Neurology
Portland, Oregon, 97239, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 29913017DERIVEDSchenk 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.
PMID: 27886407DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jay Soto
Clinical Trials Prothena Biosciences Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2014
First Posted
June 6, 2014
Study Start
June 1, 2014
Primary Completion
September 1, 2016
Last Updated
October 21, 2016
Record last verified: 2016-10