Back to resultsA Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Saline
Carbidopa
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous
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
- 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 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
Placebo Comparator
Placebo Comparator
Arm Label
Carbidopa
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence and frequency of adverse events, withdrawal rate
1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events
Secondary Outcome Measures
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma
Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma
Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01229332
Brief Title
A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
Official Title
A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
5. Study Description
Brief Summary
A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 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 carbidopa solution continuous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbidopa
Arm Type
Placebo Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Continuous 24 h administration
Intervention Type
Drug
Intervention Name(s)
Carbidopa
Intervention Description
Continuous 24 h administration
Primary Outcome Measure Information:
Title
Incidence and frequency of adverse events, withdrawal rate
Description
1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events
Time Frame
Up to 2 days
Secondary Outcome Measure Information:
Title
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma
Description
Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC
Time Frame
Up to 2 days
Title
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma
Description
Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC
Time Frame
Up to 2 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
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 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 Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
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