Clinical trial NCT02157714: Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Prothena Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2014-06-06
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety and tolerability as determined by number of subjects with adverse events
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 6 months
Secondary outcomes:
measure: Immunogenicity as determined by measurement of anti-PRX002 antibodies
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Bingham Farms
country: United States
facility: QUEST Research Institute
state: Michigan
city: Portland
country: United States
facility: Oregon Health and Science University, Department of Neurology
state: Oregon
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Clinical Trials Prothena Biosciences Inc
name: Jay Soto
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.