NCT01229332CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- NeuroDerm Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Incidence and frequency of adverse events, withdrawal rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Carbidopa
Placebo Comparator
Intervention: Carbidopa (Drug)
Placebo
Placebo Comparator
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Incidence and frequency of adverse events, withdrawal rate
Time Frame: Up to 2 days
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 Outcomes
- Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma(Up to 2 days)
Investigators
Study Sites (1)
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