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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations

NCT01229332•NeuroDerm Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

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. 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).

Locations (1)

Hadassah Medical Center

Jerusalem, Israel

Key Dates

Start Date

January 1, 2011

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

December 6, 2011

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Saline

DRUG

Carbidopa

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations