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

NCT ID: NCT01725802

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-16
• Study Completion Date: 2013-02-26

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment sequence A

Period 1. ND0612; Period 2. Placebo

Group Type: EXPERIMENTAL

Levodopa/carbidopa solution for SC administration

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Treatment sequence B

Period 1. Placebo; Period 2. ND0612

Group Type: EXPERIMENTAL

Levodopa/carbidopa solution for SC administration

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Levodopa/carbidopa solution for SC administration

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

ND0612; Saline

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroDerm Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

ND0612/002

Identifier Type: -

Identifier Source: org_study_id