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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:
ClinicalTrials.gov Identifier:
NCT01229332
First Posted: October 27, 2010
Last Update Posted: December 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NeuroDerm Ltd.
  Purpose
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 Intervention Phase
Parkinson's Disease Drug: Saline Drug: Carbidopa Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by NeuroDerm Ltd.:

Primary Outcome Measures:
  • Incidence and frequency of adverse events, withdrawal rate [ Time Frame: 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:
  • Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma [ Time Frame: Up to 2 days ]
    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 ]
    Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC


Enrollment: 24
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Carbidopa Drug: Carbidopa
Continuous 24 h administration
Placebo Comparator: Placebo Drug: Saline
Continuous 24 h administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229332


Locations
Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
  More Information

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT01229332     History of Changes
Other Study ID Numbers: ND0611/002
First Submitted: October 3, 2010
First Posted: October 27, 2010
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by NeuroDerm Ltd.:
Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors