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

NCT03462043 | Withdrawn Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: ND0612-315
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Sequence A

ACTIVE COMPARATOR

Combination Product: ND0612; Combination Product: CLES

Sequence B

ACTIVE COMPARATOR

Combination Product: ND0612; Combination Product: CLES

Sequence C

ACTIVE COMPARATOR

Combination Product: ND0612; Combination Product: CLES

Sequence D

ACTIVE COMPARATOR

Combination Product: ND0612; Combination Product: CLES

Interventions

ND0612 COMBINATION_PRODUCT

s.c. infused

Sequence A; Sequence B; Sequence C; Sequence D

CLES COMBINATION_PRODUCT

Carbidopa-Levodopa Enteral Suspension.

Sequence A; Sequence B; Sequence C; Sequence D

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (1)

91601

Roma, 00163, Italy

Location

Study Officials

• Osnat Ehrman

  NeuroDerm Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: April 10, 2018
• Primary Completion: November 20, 2018
• Study Completion: December 30, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

IT (1)