Back to resultsA Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
levodopa and carbidopa solution for SC administration
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
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).
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
levodopa and carbidopa
placebo to levodopa and carbidopa
Arm Description
levodopa and carbidopa solution
saline
Outcomes
Primary Outcome Measures
Incidence and frequency of adverse events
Incidence and frequency of adverse events
Adverse events reporting related to the ND0612 application, local safety score
Withdrawal rate
Withdrawal rates and discontinuations due to adverse events
Secondary Outcome Measures
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:
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01725802
Brief Title
A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levodopa and carbidopa
Arm Type
Experimental
Arm Description
levodopa and carbidopa solution
Arm Title
placebo to levodopa and carbidopa
Arm Type
Placebo Comparator
Arm Description
saline
Intervention Type
Drug
Intervention Name(s)
levodopa and carbidopa solution for SC administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Incidence and frequency of adverse events
Description
Incidence and frequency of adverse events
Adverse events reporting related to the ND0612 application, local safety score
Time Frame
up to 8 weeks
Title
Withdrawal rate
Description
Withdrawal rates and discontinuations due to adverse events
Time Frame
2 days
Secondary Outcome Measure Information:
Title
LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC
Description
LD PK profile after oral LD dosing administered with or without ND0612:
Time Frame
Up to 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
We'll reach out to this number within 24 hrs