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

October 3, 2010
December 4, 2011
January 2011
November 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01229332 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: Saline
    Continuous 24 h administration
  • Drug: Carbidopa
    Continuous 24 h administration
  • Placebo Comparator: Carbidopa
    Intervention: Drug: Carbidopa
  • Placebo Comparator: Placebo
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2011
November 2011   (final data collection date for primary outcome measure)

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).
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01229332
ND0611/002
Not Provided
NeuroDerm Ltd.
NeuroDerm Ltd.
Not Provided
Not Provided
NeuroDerm Ltd.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP