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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

This study has been completed.
Information provided by (Responsible Party):
NeuroDerm Ltd. Identifier:
First received: November 4, 2012
Last updated: March 31, 2016
Last verified: June 2013
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 Intervention Phase
Parkinson's Disease Drug: levodopa and carbidopa solution for SC administration Drug: Placebo 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/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

Resource links provided by NLM:

Further study details as provided by NeuroDerm Ltd.:

Primary Outcome Measures:
  • 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

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

Secondary Outcome Measures:
  • 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:

Enrollment: 8
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: levodopa and carbidopa
levodopa and carbidopa solution
Drug: levodopa and carbidopa solution for SC administration
Placebo Comparator: placebo to levodopa and carbidopa
Drug: Placebo
Other Name: Saline

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.


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

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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Please refer to this study by its identifier: NCT01725802

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

Responsible Party: NeuroDerm Ltd. Identifier: NCT01725802     History of Changes
Other Study ID Numbers: ND0612/002
Study First Received: November 4, 2012
Last Updated: March 31, 2016

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pharmaceutical Solutions
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 processed this record on August 17, 2017