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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02096601

Enrollment

Registered

2014-03-26

Start date

2014-08-11

Completion date

2015-03-15

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery

Brief summary

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).

Detailed description

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.

Interventions

DRUGLD/CD SC solution

Levodopa/carbidopa SC solution

DRUGEntacapone

Entacapone 200 mg oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events frequency	Up to 6 weeks
LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.	Days 1, 2, 3 and 4
Tolerability: Number of patients who discontinued due to adverse events	Up to 6 weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026