A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients

A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01725802

Enrollment

Registered

2012-11-14

Start date

2012-12-16

Completion date

2013-02-26

Last updated

2024-05-01

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

Conditions

Parkinson's Disease

Brief summary

In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.

Detailed description

Design: single center, double-blind, randomized, placebo-controlled, crossover study. Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments. Population: Eight (8) PD subjects.

Interventions

DRUGLevodopa/carbidopa solution for SC administration

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Men and women with idiopathic Parkinson's disease * Subjects must experience motor fluctuations associated with LD/CD dosing * Modified Hoehn and Yahr stage \< 5 * Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy * Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening. * Subjects must be age 30 or older. * Subjects must be willing and able to give informed consent. Main

Exclusion criteria

* Subjects with a clinically significant or unstable medical or surgical condition * Subjects with clinically significant psychiatric illness. * Pre-menopausal women, not using birth control method. * Subjects who have taken experimental medications within 60 days prior to baseline. * Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).

Design outcomes

Primary

Measure	Time frame	Description
Incidence and frequency of adverse events	up to 8 weeks	1. Incidence and frequency of adverse events 2. Adverse events reporting related to the ND0612 application, local safety score
Withdrawal rate	2 days	Withdrawal rates and discontinuations due to adverse events

Secondary

Measure	Time frame	Description
LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC	Up to 2 days	LD PK profile after oral LD dosing administered with or without ND0612:

Countries

Israel

Outcome results

None listed

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