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A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Levodopa and carbidopa SC solution
Oral levodopa and carbidopa
Sponsored by
NeuroDerm Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female PD patients of any race aged 30 to 80 years
  2. PD diagnosis consistent with the UK PD Society Brain Bank criteria.
  3. Stable doses of anti PD drugs for at least 30 days
  4. PD patients with well-defined morning "OFF" and a good response to LD
  5. MMSE score > 26
  6. No clinically significant medical, psychiatric or laboratory abnormalities

Exclusion Criteria:

  1. Atypical or secondary Parkinsonism.
  2. Acute psychosis or hallucinations.
  3. Subjects treated with neuroleptics
  4. History of melanoma or significant skin disorders.
  5. Prior neurosurgical procedure for PD.
  6. Patients with a history of drug abuse or alcoholism
  7. Clinically significant ECG abnormalities.
  8. Renal or liver dysfunction
  9. Subjects who have participated in another clinical study within 30 days

Sites / Locations

  • Hadassah Medical Center
  • Tel Aviv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ND0612

Oral levodopa and carbidopa

Arm Description

Levodopa and carbidopa SC solution

Oral levodopa and carbidopa

Outcomes

Primary Outcome Measures

Adverse events frequency
LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.
Tolerability: Number of patients who discontinued due to adverse events

Secondary Outcome Measures

Full Information

First Posted
March 18, 2014
Last Updated
May 24, 2023
Sponsor
NeuroDerm Ltd.
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT02096601
Brief Title
A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients
Official Title
A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/ infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if continuous delivery of levodopa and carbidopa can provide reduced variability in plasma concentration; to test and compare the PK profile of high and low concentrations of CD; to assess preliminary efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ND0612
Arm Type
Experimental
Arm Description
Levodopa and carbidopa SC solution
Arm Title
Oral levodopa and carbidopa
Arm Type
Active Comparator
Arm Description
Oral levodopa and carbidopa
Intervention Type
Drug
Intervention Name(s)
Levodopa and carbidopa SC solution
Other Intervention Name(s)
ND0612
Intervention Description
Levodopa and carbidopa SC solution
Intervention Type
Drug
Intervention Name(s)
Oral levodopa and carbidopa
Intervention Description
Oral levodopa and carbidopa
Primary Outcome Measure Information:
Title
Adverse events frequency
Time Frame
Up to 6 weeks
Title
LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.
Time Frame
Days 1, 2, 3 and 4
Title
Tolerability: Number of patients who discontinued due to adverse events
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female PD patients of any race aged 30 to 80 years PD diagnosis consistent with the UK PD Society Brain Bank criteria. Stable doses of anti PD drugs for at least 30 days PD patients with well-defined morning "OFF" and a good response to LD MMSE score > 26 No clinically significant medical, psychiatric or laboratory abnormalities Exclusion Criteria: Atypical or secondary Parkinsonism. Acute psychosis or hallucinations. Subjects treated with neuroleptics History of melanoma or significant skin disorders. Prior neurosurgical procedure for PD. Patients with a history of drug abuse or alcoholism Clinically significant ECG abnormalities. Renal or liver dysfunction Subjects who have participated in another clinical study within 30 days
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

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A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients

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