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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Placebo; Drug: PRX002

• Registration Number: NCT02157714
• Lead Sponsor: Prothena Biosciences Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Primary Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
PRX002	PRX002	PRX002

Primary Outcome Measures

Name	Time	Method
Determination of pharmacokinetics parameters	up to 6 months	minimum observed concentration (Cmin)
Safety and tolerability as determined by number of subjects with adverse events	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Immunogenicity as determined by measurement of anti-PRX002 antibodies	up to 3 months	Multiple clinical and exploratory biomarkers will be assessed

Trial Locations

Locations (8)

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States

Collaborative Neuroscience Network, LLC; 🇺🇸 Long Beach, California, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Compass Research, LLC; 🇺🇸 Orlando, Florida, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

QUEST Research Institute; 🇺🇸 Bingham Farms, Michigan, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Oregon Health and Science University, Department of Neurology; 🇺🇸 Portland, Oregon, United States