Back to resultsA 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
Primary Purpose
Parkinson
Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
ND0612
CLES
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson
Eligibility Criteria
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
Sites / Locations
- 91601
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sequence A
Sequence B
Sequence C
Sequence D
Arm Description
Outcomes
Primary Outcome Measures
Bioavailability
To assess relative bioavailability of levodopa (LD) administered as ND0612, infused subcutaneously (s.c.), versus LD administered as carbidopa-levodopa enteral suspension (CLES)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03462043
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Decision to change the study design
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Active Comparator
Arm Title
Sequence B
Arm Type
Active Comparator
Arm Title
Sequence C
Arm Type
Active Comparator
Arm Title
Sequence D
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
ND0612
Intervention Description
s.c. infused
Intervention Type
Combination Product
Intervention Name(s)
CLES
Intervention Description
Carbidopa-Levodopa Enteral Suspension.
Primary Outcome Measure Information:
Title
Bioavailability
Description
To assess relative bioavailability of levodopa (LD) administered as ND0612, infused subcutaneously (s.c.), versus LD administered as carbidopa-levodopa enteral suspension (CLES)
Time Frame
6-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osnat Ehrman
Organizational Affiliation
NeuroDerm Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
91601
City
Roma
ZIP/Postal Code
00163
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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
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