Back to resultsA Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (ND0612/003)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Levodopa and carbidopa
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery, Patch-pump
Eligibility Criteria
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
- Subjects who are treated with dopaminergic agonists and other anti-PD drugs should be on stable doses
- 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
Exclusion Criteria:
- Subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa.
- Subjects with a clinically significant or unstable medical or surgical condition
- History of melanoma or significant skin disorders
- Subjects with significant cognitive impairment
- Subjects treated with unstable doses of dopaminergic agonists, anticholinergics, Monoamine oxidase (MAO)-B inhibitors, or antipsychotics
- Subjects with clinically significant psychiatric illness
- Subjects with a history of alcohol or substance abuse
- 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).
- Subjects with severe disabling dyskinesias.
- Subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors
Sites / Locations
- Hadassah Medical Center
- Rabin Medical Center
- Tel Aviv Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ND0612
Placebo
Arm Description
levodopa and carbidopa solution
Saline
Outcomes
Primary Outcome Measures
Safety
1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0612 subcutaneous administration, Draize score 3. Vital signs, physical exam, Laboratory measurements
Levodopa pharmacokinetics (LD PK)
LD PK parameters: Cmax, Area under the Curve (AUC), T>1000ng/ml, through levels at baseline and during treatment at 14 days.
Tolerability
Withdrawal rates and discontinuations due to adverse events
Secondary Outcome Measures
LD dose adjustment
Change in oral LD total daily dose, change in number of oral LD doses during the first 2 weeks, use of rescue therapy during the third week.
Pump Usability
Simulated usability study, formative Pump usability evaluation. Human factor study. Training on the use of the pump will be performed and questionnaire will be filled to assess the ease of use of the pump and the efficiency of the training.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01883505
Brief Title
A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612
Acronym
ND0612/003
Official Title
A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (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
This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD) subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
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, Patch-pump
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ND0612
Arm Type
Experimental
Arm Description
levodopa and carbidopa solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
Levodopa and carbidopa
Other Intervention Name(s)
Levodopa and carbidopa or saline
Intervention Description
Subcutaneous continuous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Subcutaneous continuous administration
Primary Outcome Measure Information:
Title
Safety
Description
1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0612 subcutaneous administration, Draize score 3. Vital signs, physical exam, Laboratory measurements
Time Frame
14 days
Title
Levodopa pharmacokinetics (LD PK)
Description
LD PK parameters: Cmax, Area under the Curve (AUC), T>1000ng/ml, through levels at baseline and during treatment at 14 days.
Time Frame
1hr and 2hr predose, 0h, 0.5 hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr, 9hr and 10hr hours post oral LD dose
Title
Tolerability
Description
Withdrawal rates and discontinuations due to adverse events
Time Frame
14 days
Secondary Outcome Measure Information:
Title
LD dose adjustment
Description
Change in oral LD total daily dose, change in number of oral LD doses during the first 2 weeks, use of rescue therapy during the third week.
Time Frame
14 days
Title
Pump Usability
Description
Simulated usability study, formative Pump usability evaluation. Human factor study. Training on the use of the pump will be performed and questionnaire will be filled to assess the ease of use of the pump and the efficiency of the training.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Subjects who are treated with dopaminergic agonists and other anti-PD drugs should be on stable doses
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
Exclusion Criteria:
Subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa.
Subjects with a clinically significant or unstable medical or surgical condition
History of melanoma or significant skin disorders
Subjects with significant cognitive impairment
Subjects treated with unstable doses of dopaminergic agonists, anticholinergics, Monoamine oxidase (MAO)-B inhibitors, or antipsychotics
Subjects with clinically significant psychiatric illness
Subjects with a history of alcohol or substance abuse
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).
Subjects with severe disabling dyskinesias.
Subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612
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