A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612

Parkinson's Disease Clinical Trial

— ND0612/003  

Official title:

A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883505
• Other study ID #: ND0612/003
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2014
• Est. completion date: April 26, 2015

Study information

• Verified date: January 2024
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD) subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 26, 2015
• Est. primary completion date: April 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• 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. Subjects who are treated with dopaminergic agonists and other anti-PD drugs should be on stable doses

6. 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.

7. Subjects must be age 30 or older.

8. Subjects must be willing and able to give informed consent

Exclusion Criteria:

1. Subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa.

2. Subjects with a clinically significant or unstable medical or surgical condition

3. History of melanoma or significant skin disorders

4. Subjects with significant cognitive impairment

5. Subjects treated with unstable doses of dopaminergic agonists, anticholinergics, Monoamine oxidase (MAO)-B inhibitors, or antipsychotics

6. Subjects with clinically significant psychiatric illness

7. Subjects with a history of alcohol or substance abuse

8. Subjects who have taken experimental medications within 60 days prior to baseline.

9. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).

10. Subjects with severe disabling dyskinesias.

11. Subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Levodopa and carbidopa
Subcutaneous continuous administration
• Placebo
Subcutaneous continuous administration

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
NeuroDerm Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0612 subcutaneous administration, Draize score 3. Vital signs, physical exam, Laboratory measurements	14 days
Primary	Levodopa pharmacokinetics (LD PK)	LD PK parameters: Cmax, Area under the Curve (AUC), T>1000ng/ml, through levels at baseline and during treatment at 14 days.	1hr and 2hr predose, 0h, 0.5 hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr, 9hr and 10hr hours post oral LD dose
Primary	Tolerability	Withdrawal rates and discontinuations due to adverse events	14 days
Secondary	LD dose adjustment	Change in oral LD total daily dose, change in number of oral LD doses during the first 2 weeks, use of rescue therapy during the third week.	14 days
Secondary	Pump Usability	Simulated usability study, formative Pump usability evaluation. Human factor study. Training on the use of the pump will be performed and questionnaire will be filled to assess the ease of use of the pump and the efficiency of the training.	14 days