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

• Sponsor: NeuroDerm Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01229332
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Saline; Drug: Carbidopa	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence and frequency of adverse events, withdrawal rate [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 Outcome Measures

1. Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma [Up to 2 days]

   Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC

2. Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma [Up to 2 days]

   Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Center	Jerusalem		Israel

Sponsors and Collaborators

• NeuroDerm Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NeuroDerm Ltd.
• ClinicalTrials.gov Identifier: NCT01229332
• Other Study ID Numbers: ND0611/002
• First Posted: Oct 27, 2010
• Last Update Posted: Dec 6, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by NeuroDerm Ltd.: Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous
• Additional relevant MeSH terms: Parkinson Disease; Carbidopa

Study Results

No Results Posted as of Dec 6, 2011