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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157714
• Other study ID #: PRX002-CL002
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2014
• Last updated: October 19, 2016
• Start date: June 2014

Study information

• Verified date: October 2016
• Source: Prothena Biosciences Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• PRX002

Other:
• Placebo

Locations

Country	Name	City	State
United States	QUEST Research Institute	Bingham Farms	Michigan
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	MD Clinical	Hallandale Beach	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Compass Research, LLC	Orlando	Florida
United States	Oregon Health and Science University, Department of Neurology	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Prothena Biosciences Limited	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as determined by number of subjects with adverse events		up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	maximum concentration (Cmax)	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	time of the maximum measured concentration (Tmax)	up to 6 months	Yes
Primary	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	Yes
Primary	Determination of pharmacokinetics parameters	area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	elimination rate constant	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	terminal elimination half life (t½)	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	clearance (CL)	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	apparent volume of distribution (Vd)	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	average concentration over a dosing interval (Cav)	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	area under the plasma concentration-time curve for a dosing interval (AUCtau)	up to 6 months	Yes
Primary	Determination of pharmacokinetics parameters	minimum observed concentration (Cmin)	up to 6 months	Yes
Secondary	Immunogenicity as determined by measurement of anti-PRX002 antibodies	Multiple clinical and exploratory biomarkers will be assessed	up to 3 months	Yes