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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX002 | Experimental | PRX002 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX002 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as determined by number of subjects with adverse events | up to 6 months | |
| Determination of pharmacokinetics parameters | maximum concentration (Cmax) | up to 6 months |
| Determination of pharmacokinetics parameters | time of the maximum measured concentration (Tmax) | up to 6 months |
| Determination of pharmacokinetics parameters | area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast) | up to 6 months |
| Determination of pharmacokinetics parameters | area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | up to 6 months |
| Determination of pharmacokinetics parameters | elimination rate constant | up to 6 months |
| Determination of pharmacokinetics parameters | terminal elimination half life (t½) | up to 6 months |
| Determination of pharmacokinetics parameters | clearance (CL) | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity as determined by measurement of anti-PRX002 antibodies | Multiple clinical and exploratory biomarkers will be assessed | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Soto | Clinical Trials Prothena Biosciences Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC | Long Beach | California | 90806 | United States | ||
| Institute for Neurodegenerative Disorders |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29913017 | Derived | 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. | |
| 27886407 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Determination of pharmacokinetics parameters | apparent volume of distribution (Vd) | up to 6 months |
| Determination of pharmacokinetics parameters | average concentration over a dosing interval (Cav) | up to 6 months |
| Determination of pharmacokinetics parameters | area under the plasma concentration-time curve for a dosing interval (AUCtau) | up to 6 months |
| Determination of pharmacokinetics parameters | minimum observed concentration (Cmin) | up to 6 months |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| QUEST Research Institute | Bingham Farms | Michigan | 48025 | United States |
| Oregon Health and Science University, Department of Neurology | Portland | Oregon | 97239 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Derived |
| 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |