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A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients

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ClinicalTrials.gov Identifier: NCT01725802
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Study Description
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Brief Summary:
In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: levodopa and carbidopa solution for SC administration Drug: Placebo Phase 1 Phase 2

Detailed Description:

Design: single center, double-blind, randomized, placebo-controlled, crossover study.

Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.

Population: Eight (8) PD subjects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
Study Start Date : December 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: levodopa and carbidopa
levodopa and carbidopa solution
 Drug: levodopa and carbidopa solution for SC administration
Placebo Comparator: placebo to levodopa and carbidopa
saline
 Drug: Placebo
Other Name: Saline


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and frequency of adverse events [ Time Frame: up to 8 weeks ]
    1. Incidence and frequency of adverse events
    2. Adverse events reporting related to the ND0612 application, local safety score

  2. Withdrawal rate [ Time Frame: 2 days ]
    Withdrawal rates and discontinuations due to adverse events


Secondary Outcome Measures :
  1. LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC [ Time Frame: Up to 2 days ]
    LD PK profile after oral LD dosing administered with or without ND0612:


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

Main 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.

Main 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).
Contacts and Locations
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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): NCT01725802


Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
More Information
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Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT01725802    
Other Study ID Numbers: ND0612/002
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: June 2013
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
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