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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Levodopa/carbidopa solution for SC administration

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence A; Period 1. ND0612; Period 2. Placebo	Drug: Placebo; Other Names: Saline; Drug: Levodopa/carbidopa solution for SC administration; Other Names: ND0612
Experimental: Treatment sequence B; Period 1. Placebo; Period 2. ND0612	Drug: Placebo; Other Names: Saline; Drug: Levodopa/carbidopa solution for SC administration; Other Names: ND0612

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NeuroDerm Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2012
• Primary Completion (Actual): February 26, 2013
• Study Completion (Actual): February 26, 2013

Study Registration Dates

• First Submitted: November 4, 2012
• First Submitted That Met QC Criteria: November 8, 2012
• First Posted (Estimated): November 14, 2012

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Aromatic Amino Acid Decarboxylase Inhibitors; Levodopa; Carbidopa
• Other Study ID Numbers: ND0612/002