This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD) subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Subcutaneous continuous administration
Subcutaneous continuous administration
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Safety
1\. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0612 subcutaneous administration, Draize score 3. Vital signs, physical exam, Laboratory measurements
Time frame: 14 days
Levodopa pharmacokinetics (LD PK)
LD PK parameters: Cmax, Area under the Curve (AUC), T\>1000ng/ml, through levels at baseline and during treatment at 14 days.
Time frame: 1hr and 2hr predose, 0h, 0.5 hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr, 9hr and 10hr hours post oral LD dose
Tolerability
Withdrawal rates and discontinuations due to adverse events
Time frame: 14 days
LD dose adjustment
Change in oral LD total daily dose, change in number of oral LD doses during the first 2 weeks, use of rescue therapy during the third week.
Time frame: 14 days
Pump Usability
Simulated usability study, formative Pump usability evaluation. Human factor study. Training on the use of the pump will be performed and questionnaire will be filled to assess the ease of use of the pump and the efficiency of the training.
Time frame: 14 days
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