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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2016 |
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Main ID: |
NCT02157714 |
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Date of registration:
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04/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02157714 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Jay Soto |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Trials Prothena Biosciences Inc |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: PRX002
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Other: Placebo
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Primary Outcome(s)
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Safety and tolerability as determined by number of subjects with adverse events
[Time Frame: up to 6 months]
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Determination of pharmacokinetics parameters
[Time Frame: up to 6 months]
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Secondary Outcome(s)
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Immunogenicity as determined by measurement of anti-PRX002 antibodies
[Time Frame: up to 3 months]
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Secondary ID(s)
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PRX002-CL002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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