A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension

A Pivotal, Open-Label, Randomized, Crossover Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension

This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.

Study Overview

• Status: Withdrawn
• Conditions: Parkinson
• Intervention / Treatment: Combination product: ND0612; Combination product: CLES

Detailed Description

This study will be an open-label, randomized, crossover study to assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00163
    • 91601

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with Advanced PD treated with LD/CD at a dose of at least 800 mg LD
• Female patients must have a negative pregnancy test at screening and at admission.
• Patients must have a body mass index (BMI) within the range of 18.5 - 35 kg/m2, where BMI = body weight (kg) / height (m2) at screening.
• Must be willing and able to communicate and participate in the whole study.
• Must provide written informed consent.
• Must agree to use an adequate method of contraception (per local independent ethics committee requirements).
• Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration

Exclusion Criteria:

• Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for study entry or potentially unable to complete all aspects of the study.
• Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the screening visit.
• Patients with a history of drug abuse or alcoholism within the past 12 months prior to screening or positive drugs of abuse or alcohol test result at the screening visit and/or on admission.
• Clinically significant electrocardiogram (ECG) rhythm abnormalities.
• Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.5 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
• Psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study, including dementia, or patients who are considered to be violent or at suicidal risk by the Investigator.
• Blood loss of greater than 500 mL within the previous 3 months prior to first dosing.
• use of any medication from the prohibited concomitant therapies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sequence A	Combination product: ND0612; s.c. infused; Combination product: CLES; Carbidopa-Levodopa Enteral Suspension.
Active Comparator: Sequence B	Combination product: ND0612; s.c. infused; Combination product: CLES; Carbidopa-Levodopa Enteral Suspension.
Active Comparator: Sequence C	Combination product: ND0612; s.c. infused; Combination product: CLES; Carbidopa-Levodopa Enteral Suspension.
Active Comparator: Sequence D	Combination product: ND0612; s.c. infused; Combination product: CLES; Carbidopa-Levodopa Enteral Suspension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioavailability	To assess relative bioavailability of levodopa (LD) administered as ND0612, infused subcutaneously (s.c.), versus LD administered as carbidopa-levodopa enteral suspension (CLES)	6-7 days

Collaborators and Investigators

• Sponsor: NeuroDerm Ltd.
• Investigators: Study Director: Osnat Ehrman, NeuroDerm Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Anticipated): November 20, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

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
• Other Study ID Numbers: ND0612-315

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes