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Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRX002
Placebo
Sponsored by
Prothena Biosciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Collaborative Neuroscience Network, LLC
  • Institute for Neurodegenerative Disorders
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • MD Clinical
  • Compass Research, LLC
  • QUEST Research Institute
  • Oregon Health and Science University, Department of Neurology
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRX002

Placebo

Arm Description

PRX002

Placebo

Outcomes

Primary Outcome Measures

Safety and tolerability as determined by number of subjects with adverse events
Determination of pharmacokinetics parameters
maximum concentration (Cmax)
Determination of pharmacokinetics parameters
time of the maximum measured concentration (Tmax)
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters
elimination rate constant
Determination of pharmacokinetics parameters
terminal elimination half life (t½)
Determination of pharmacokinetics parameters
clearance (CL)
Determination of pharmacokinetics parameters
apparent volume of distribution (Vd)
Determination of pharmacokinetics parameters
average concentration over a dosing interval (Cav)
Determination of pharmacokinetics parameters
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Determination of pharmacokinetics parameters
minimum observed concentration (Cmin)

Secondary Outcome Measures

Immunogenicity as determined by measurement of anti-PRX002 antibodies
Multiple clinical and exploratory biomarkers will be assessed

Full Information

First Posted
June 4, 2014
Last Updated
October 19, 2016
Sponsor
Prothena Biosciences Limited
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02157714
Brief Title
Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prothena Biosciences Limited
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRX002
Arm Type
Experimental
Arm Description
PRX002
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PRX002
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability as determined by number of subjects with adverse events
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
maximum concentration (Cmax)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
time of the maximum measured concentration (Tmax)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
elimination rate constant
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
terminal elimination half life (t½)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
clearance (CL)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
apparent volume of distribution (Vd)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
average concentration over a dosing interval (Cav)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Time Frame
up to 6 months
Title
Determination of pharmacokinetics parameters
Description
minimum observed concentration (Cmin)
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Immunogenicity as determined by measurement of anti-PRX002 antibodies
Description
Multiple clinical and exploratory biomarkers will be assessed
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Soto
Organizational Affiliation
Clinical Trials Prothena Biosciences Inc
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
QUEST Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Oregon Health and Science University, Department of Neurology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29913017
Citation
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.
Results Reference
derived
PubMed Identifier
27886407
Citation
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.
Results Reference
derived

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Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease

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