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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: PRX002 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : September 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PRX002
PRX002
 Drug: PRX002
Placebo Comparator: Placebo
Placebo
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability as determined by number of subjects with adverse events [ Time Frame: up to 6 months ]
  2. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    maximum concentration (Cmax)

  3. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    time of the maximum measured concentration (Tmax)

  4. 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)

  5. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

  6. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    elimination rate constant

  7. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    terminal elimination half life (t½)

  8. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    clearance (CL)

  9. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    apparent volume of distribution (Vd)

  10. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    average concentration over a dosing interval (Cav)

  11. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    area under the plasma concentration-time curve for a dosing interval (AUCtau)

  12. Determination of pharmacokinetics parameters [ Time Frame: up to 6 months ]
    minimum observed concentration (Cmin)


Secondary Outcome Measures :
  1. Immunogenicity as determined by measurement of anti-PRX002 antibodies [ Time Frame: up to 3 months ]
    Multiple clinical and exploratory biomarkers will be assessed


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157714


Locations
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United States, California
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
MD Clinical
Hallandale Beach, Florida, United States, 33009
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, Michigan
QUEST Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Oregon
Oregon Health and Science University, Department of Neurology
Portland, Oregon, United States, 97239
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Prothena Biosciences Limited
Hoffmann-La Roche
Investigators
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Study Director: Jay Soto Clinical Trials Prothena Biosciences Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prothena Biosciences Limited
ClinicalTrials.gov Identifier: NCT02157714    
Other Study ID Numbers: PRX002-CL002
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases