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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuroDerm Ltd.
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Treatments: Carbidopa; Levodopa; Pharmaceutical Solutions

Criteria

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