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

A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD

An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase [COMT] inhibitor) in PD subjects with well-defined morning "OFF" and a good response to LD. Exploratory efficacy parameters were collected (early evidence of effectiveness as part of Phase 1).

PD subjects were randomized in Low or High LD dose study group in 1:1 ratio. Each patient received singe doses ND0612 over 3 days: Day 1. LD/CD 60/7.5 mg/mL, Day 2. LD/CD 60/14 mg, and Day 3. LD/CD 60/14 mg/mL with Entacapone.

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