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

NCT ID: NCT01229332

Last Updated: 2011-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Carbidopa

Group Type PLACEBO_COMPARATOR

Carbidopa

Intervention Type DRUG

Continuous 24 h administration

Placebo

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Continuous 24 h administration

Interventions

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Saline

Continuous 24 h administration

Intervention Type DRUG

Carbidopa

Continuous 24 h administration

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroDerm Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ND0611/002

Identifier Type: -

Identifier Source: org_study_id