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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Levodopa/carbidopa solution for SC administration; Drug: Placebo

• Registration Number: NCT01725802
• Lead Sponsor: NeuroDerm Ltd.

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.

Study Timeline

• Study First Submitted: 2012-11-04
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-14
• Study Start: 2012-12-16
• Primary Completion: 2013-02-26
• Study Completion: 2013-02-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence A	Levodopa/carbidopa solution for SC administration	Period 1. ND0612; Period 2. Placebo
Treatment sequence A	Placebo	Period 1. ND0612; Period 2. Placebo
Treatment sequence B	Levodopa/carbidopa solution for SC administration	Period 1. Placebo; Period 2. ND0612
Treatment sequence B	Placebo	Period 1. Placebo; Period 2. ND0612

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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:

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel