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

Arm | Intervention/treatment |
---|---|
Experimental: PRX002
PRX002
|
Drug: PRX002 |
Placebo Comparator: Placebo
Placebo
|
Other: Placebo |
- 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)
- Immunogenicity as determined by measurement of anti-PRX002 antibodies [ Time Frame: up to 3 months ]Multiple clinical and exploratory biomarkers will be assessed

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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 |
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

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
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 |
Study Director: | Jay Soto | Clinical Trials Prothena Biosciences Inc |
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 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |