A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuroDerm Ltd.
• Treatments: Carbidopa; Levodopa

Criteria

Inclusion Criteria:

1. Men and women with idiopathic Parkinson's disease

2. Subjects must experience motor fluctuations associated with LD/CD dosing

3. Modified Hoehn and Yahr stage < 5

4. Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy

5. 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.

6. Subjects must be age 30 or older.

7. Subjects must be willing and able to give informed consent.

Exclusion Criteria:

1. Subjects with a clinically significant or unstable medical or surgical condition

2. Subjects with clinically significant psychiatric illness.

3. Pre-menopausal women, not using birth control method.

4. Subjects who have taken experimental medications within 60 days prior to baseline.

5. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).