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A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (ND0612-003)

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. Identifier: NCT01883505
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : April 1, 2016
Information provided by (Responsible Party):
NeuroDerm Ltd.

Brief Summary:
This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD) subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Levodopa and carbidopa Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612
Study Start Date : December 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ND0612
levodopa and carbidopa solution
Drug: Levodopa and carbidopa
Subcutaneous continuous administration
Other Name: Levodopa and carbidopa or saline

Placebo Comparator: Placebo
Drug: Placebo
Subcutaneous continuous administration
Other Name: Saline

Primary Outcome Measures :
  1. Safety [ Time Frame: 14 days ]
    1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0612 subcutaneous administration, Draize score 3. Vital signs, physical exam, Laboratory measurements

  2. Levodopa pharmacokinetics (LD PK) [ Time Frame: 1hr and 2hr predose, 0h, 0.5 hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr, 9hr and 10hr hours post oral LD dose ]
    LD PK parameters: Cmax, Area under the Curve (AUC), T>1000ng/ml, through levels at baseline and during treatment at 14 days.

  3. Tolerability [ Time Frame: 14 days ]
    Withdrawal rates and discontinuations due to adverse events

Secondary Outcome Measures :
  1. LD dose adjustment [ Time Frame: 14 days ]
    Change in oral LD total daily dose, change in number of oral LD doses during the first 2 weeks, use of rescue therapy during the third week.

  2. Pump Usability [ Time Frame: 14 days ]
    Simulated usability study, formative Pump usability evaluation. Human factor study. Training on the use of the pump will be performed and questionnaire will be filled to assess the ease of use of the pump and the efficiency of the training.

Information from the National Library of Medicine

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

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. Subjects who are treated with dopaminergic agonists and other anti-PD drugs should be on stable doses
  6. 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.
  7. Subjects must be age 30 or older.
  8. Subjects must be willing and able to give informed consent

Exclusion Criteria:

  1. Subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa.
  2. Subjects with a clinically significant or unstable medical or surgical condition
  3. History of melanoma or significant skin disorders
  4. Subjects with significant cognitive impairment
  5. Subjects treated with unstable doses of dopaminergic agonists, anticholinergics, Monoamine oxidase (MAO)-B inhibitors, or antipsychotics
  6. Subjects with clinically significant psychiatric illness
  7. Subjects with a history of alcohol or substance abuse
  8. Subjects who have taken experimental medications within 60 days prior to baseline.
  9. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
  10. Subjects with severe disabling dyskinesias.
  11. Subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors

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 identifier (NCT number): NCT01883505

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Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
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Responsible Party: NeuroDerm Ltd. Identifier: NCT01883505    
Other Study ID Numbers: ND0612-003
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2014
Keywords provided by NeuroDerm Ltd.:
Motor fluctuations
levodopa pharmacokinetics
levodopa and carbidopa solution
continuous subcutaneous delivery
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
Neurodegenerative Diseases
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