This is a phase I, randomised, placebo-controlled study to assess the safety and tolerability of two 2-weeks cycles of i.c.v. administration of sNN0031 infusion solution to patients with PD of moderate severity with persisting on-off symptoms in spite of other PD medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.
I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.
Klinikum-Bremerhaven
Bremerhaven, Germany
Lund University Hospital
Lund, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
King's College Hospital
London, United Kingdom
Tolerability of sNN0031 [Number of Adverse Events (AE) and Serious Adverse Events (SAE) occurring in each group over the study duration]
Number of AEs and SAEs occurring in each group over the study duration
Time frame: 10 months
Peak concentrations of sNN0031 in cerebrospinal fluid during two 14 day continuous infusion cycles
To explore peak concentrations of Platelet Derived Growth Factor-BB (PDGF-BB) levels in cerebrospinal fluid (CSF) during two different treatment cycles of 70 μg sNN0031 each separated by 3 months
Time frame: 14 days x 2
Pump flow error rate
Performance of the Medtronic SynchroMed® II Infusion System - Pump flow error rate within 25%
Time frame: 10 months
Number of patients with AEs related to the Implanted Infusion System
Number of AEs and SAEs related to the Medtronic SynchroMed® II Infusion System occurring in each group over the study duration
Time frame: 10 months
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John Radcliffe Hospital
Oxford, United Kingdom