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

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ClinicalTrials.gov Identifier: NCT02157714
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : October 21, 2016
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Prothena Biosciences Limited

Tracking Information
First Submitted Date  ICMJE June 4, 2014
First Posted Date  ICMJE June 6, 2014
Last Update Posted Date October 21, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
  • Safety and tolerability as determined by number of subjects with adverse events [ Time Frame: up to 6 months ]
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    maximum concentration (Cmax)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    time of the maximum measured concentration (Tmax)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    elimination rate constant
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    terminal elimination half life (t½)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    clearance (CL)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    apparent volume of distribution (Vd)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    average concentration over a dosing interval (Cav)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    area under the plasma concentration-time curve for a dosing interval (AUCtau)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    minimum observed concentration (Cmin)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02157714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
Immunogenicity as determined by measurement of anti-PRX002 antibodies [ Time Frame: up to 3 months ]
Multiple clinical and exploratory biomarkers will be assessed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: PRX002
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: PRX002
    PRX002
    Intervention: Drug: PRX002
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 1, 2015)
64
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2014)
60
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02157714
Other Study ID Numbers  ICMJE PRX002-CL002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prothena Biosciences Limited
Study Sponsor  ICMJE Prothena Biosciences Limited
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Director: Jay Soto Clinical Trials Prothena Biosciences Inc
PRS Account Prothena Biosciences Limited
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP