A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients



Status:Not yet recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 80
Updated:4/2/2016
Contact:Yael Cohen, M.Pharm.
Email:yael@neuroderm.com
Phone:+97289462729

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD

An open label phase I/IIa study to evaluate the safety and tolerability of 6 different
doses/ infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if
continuous delivery of levodopa and carbidopa can provide reduced variability in plasma
concentration; to test and compare the PK profile of high and low concentrations of CD; to
assess preliminary efficacy.


Inclusion Criteria:

1. Male and female PD patients of any race aged 30 to 80 years

2. PD diagnosis consistent with the UK PD Society Brain Bank criteria.

3. Stable doses of anti PD drugs for at least 30 days

4. PD patients with well-defined morning "OFF" and a good response to LD

5. MMSE score > 26

6. No clinically significant medical, psychiatric or laboratory abnormalities

Exclusion Criteria:

1. Atypical or secondary Parkinsonism.

2. Acute psychosis or hallucinations.

3. Subjects treated with neuroleptics

4. History of melanoma or significant skin disorders.

5. Prior neurosurgical procedure for PD.

6. Patients with a history of drug abuse or alcoholism

7. Clinically significant ECG abnormalities.

8. Renal or liver dysfunction

9. Subjects who have participated in another clinical study within 30 days
We found this trial at
1
site
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
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mi
from
West Bloomfield, MI
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