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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Carbidopa; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Saline; Continuous 24 h administration
Placebo Comparator: Carbidopa	Drug: Carbidopa; Continuous 24 h administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and frequency of adverse events, withdrawal rate	1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events	Up to 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma	Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC	Up to 2 days
Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma	Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC	Up to 2 days

Collaborators and Investigators

• Sponsor: NeuroDerm Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 3, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 27, 2010

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 4, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Aromatic Amino Acid Decarboxylase Inhibitors; Carbidopa
• Other Study ID Numbers: ND0611/002