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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2011

Interventions

  • Drug: Saline
    • Continuous 24 h administration
  • Drug: Carbidopa
    • Continuous 24 h administration

Arms, Groups and Cohorts

  • Placebo Comparator: Carbidopa
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Incidence and frequency of adverse events, withdrawal rate
    • Time Frame: Up to 2 days
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NeuroDerm Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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