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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229332
• Other study ID #: ND0611/002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 3, 2010
• Last updated: December 4, 2011
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
NeuroDerm Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No