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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

NeuroDerm Ltd.

ClinicalTrials.gov Identifier:

NCT01229332

First received: October 3, 2010

Last updated: December 4, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 3, 2010
Last Updated Date	December 4, 2011
Start Date ^ICMJE	January 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2010)	Incidence and frequency of adverse events, withdrawal rate [ Time Frame: Up to 2 days ] [ Designated as safety issue: Yes ] 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01229332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2010)	Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	Drug: Saline Continuous 24 h administration Drug: Carbidopa Continuous 24 h administration
Study Arm (s)	Placebo Comparator: Carbidopa Intervention: Drug: Carbidopa Placebo Comparator: Placebo Intervention: Drug: Saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men and women with idiopathic Parkinson's disease Subjects must experience motor fluctuations associated with LD/CD dosing Modified Hoehn and Yahr stage < 5 Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy 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. Subjects must be age 30 or older. Subjects must be willing and able to give informed consent. Exclusion Criteria: Subjects with a clinically significant or unstable medical or surgical condition Subjects with clinically significant psychiatric illness. Pre-menopausal women, not using birth control method. Subjects who have taken experimental medications within 60 days prior to baseline. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01229332
Other Study ID Numbers ^ICMJE	ND0611/002
Has Data Monitoring Committee	Not Provided
Responsible Party	NeuroDerm Ltd.
Study Sponsor ^ICMJE	NeuroDerm Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NeuroDerm Ltd.
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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