A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.

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

Details

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

Criteria

Main 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.

Main 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).