A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (ND0612/003)

NeuroDerm

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Levodopa and carbidopa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01883505

ND0612/003

Details and patient eligibility

About

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 the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

Enrollment: 30 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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. Subjects who are treated with dopaminergic agonists and other anti-PD drugs should be on stable doses
6. 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.
7. Subjects must be age 30 or older.
8. Subjects must be willing and able to give informed consent

Exclusion criteria

1. Subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa.
2. Subjects with a clinically significant or unstable medical or surgical condition
3. History of melanoma or significant skin disorders
4. Subjects with significant cognitive impairment
5. Subjects treated with unstable doses of dopaminergic agonists, anticholinergics, Monoamine oxidase (MAO)-B inhibitors, or antipsychotics
6. Subjects with clinically significant psychiatric illness
7. Subjects with a history of alcohol or substance abuse
8. Subjects who have taken experimental medications within 60 days prior to baseline.
9. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
10. Subjects with severe disabling dyskinesias.
11. Subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

ND0612

Experimental group

Description:

levodopa and carbidopa solution

Treatment:

Drug: Levodopa and carbidopa

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Placebo