Status:
COMPLETED
A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
Lead Sponsor:
NeuroDerm Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE1
PHASE2
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 clinic...
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
- 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 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).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01229332
Start Date
January 1 2011
End Date
November 1 2011
Last Update
December 6 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hadassah Medical Center
Jerusalem, Israel