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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725802
• Other study ID #: ND0612/002
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2012
• Est. completion date: February 26, 2013

Study information

• Verified date: April 2024
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 26, 2013
• Est. primary completion date: February 26, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Levodopa/carbidopa solution for SC administration

• Placebo

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
NeuroDerm Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Withdrawal rate	Withdrawal rates and discontinuations due to adverse events	2 days
Secondary	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