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

NeuroDerm

Status and phase

Completed

Phase 2

Phase 1

Conditions

Parkinson's Disease

Treatments

Drug: Saline

Drug: Carbidopa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01229332

ND0611/002

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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).