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

This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Placebo; Drug: PRX002

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • Quest Research Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University, Department of Neurology
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Significant cardiac history
• Abnormal MRI
• Significant laboratory abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo
Experimental: PRX002	Drug: PRX002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity as determined by measurement of anti-PRX002 antibodies	Multiple clinical and exploratory biomarkers will be assessed	up to 3 months

Collaborators and Investigators

• Sponsor: Prothena Biosciences Limited
• Collaborators: Hoffmann-La Roche
• Investigators: Study Director: Jay Soto, Clinical Trials Prothena Biosciences Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PRX002-CL002