Overview

This trial has been completed.

Condition parkinson's disease
Treatments prx002, placebo
Phase phase 1
Sponsor Prothena Biosciences Limited
Collaborator Hoffmann-La Roche
Start date June 2014
End date September 2016
Trial size 64 participants
Trial identifier NCT02157714, PRX002-CL002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PRX002
prx002
(Placebo Comparator)
Placebo
placebo

Primary Outcomes

Measure
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
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months
Determination of pharmacokinetics parameters
time frame: up to 6 months

Secondary Outcomes

Measure
Immunogenicity as determined by measurement of anti-PRX002 antibodies
time frame: up to 3 months

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Prothena Biosciences Limited.