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Completed

NCT Number: NCT02157714

Multiple Ascending Dose Study of PRX002 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network, LLC, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRX002

Drug

Placebo

Other

Primary outcomes

  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 outcomes

  1. Immunogenicity as determined by measurement of anti-PRX002 antibodies

    Time frame: up to 3 months

    Multiple clinical and exploratory biomarkers will be assessed

Sponsors and collaborators

Lead sponsor

Prothena Biosciences Limited

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease

Important dates

Study start
2014
Primary completion
2016
First posted
Jun 6, 2014
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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