Status:
COMPLETED
A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612
Lead Sponsor:
NeuroDerm Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01883505
Start Date
January 6 2014
End Date
April 26 2015
Last Update
January 18 2024
Active Locations (3)
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1
Hadassah Medical Center
Jerusalem, Israel
2
Rabin Medical Center
Petah Tikva, Israel
3
Tel Aviv Medical Center
Tel Aviv, Israel