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A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension

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ClinicalTrials.gov Identifier: NCT03462043
Recruitment Status : Withdrawn (Decision to change the study design)
First Posted : March 12, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Study Description
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Brief Summary:
This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.

Condition or disease Intervention/treatment Phase
Parkinson Combination Product: ND0612 Combination Product: CLES Phase 3

Detailed Description:
This study will be an open-label, randomized, crossover study to assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal, Open-Label, Randomized, Crossover Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : November 20, 2018
Estimated Study Completion Date : December 30, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sequence A Combination Product: ND0612
s.c. infused

Combination Product: CLES
Carbidopa-Levodopa Enteral Suspension.
Active Comparator: Sequence B Combination Product: ND0612
s.c. infused

Combination Product: CLES
Carbidopa-Levodopa Enteral Suspension.
Active Comparator: Sequence C Combination Product: ND0612
s.c. infused

Combination Product: CLES
Carbidopa-Levodopa Enteral Suspension.
Active Comparator: Sequence D Combination Product: ND0612
s.c. infused

Combination Product: CLES
Carbidopa-Levodopa Enteral Suspension.


Outcome Measures
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Primary Outcome Measures :
  1. Bioavailability [ Time Frame: 6-7 days ]
    To assess relative bioavailability of levodopa (LD) administered as ND0612, infused subcutaneously (s.c.), versus LD administered as carbidopa-levodopa enteral suspension (CLES)


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

Inclusion Criteria:

  • Patients with Advanced PD treated with LD/CD at a dose of at least 800 mg LD
  • Female patients must have a negative pregnancy test at screening and at admission.
  • Patients must have a body mass index (BMI) within the range of 18.5 - 35 kg/m2, where BMI = body weight (kg) / height (m2) at screening.
  • Must be willing and able to communicate and participate in the whole study.
  • Must provide written informed consent.
  • Must agree to use an adequate method of contraception (per local independent ethics committee requirements).
  • Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration

Exclusion Criteria:

  • Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for study entry or potentially unable to complete all aspects of the study.
  • Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the screening visit.
  • Patients with a history of drug abuse or alcoholism within the past 12 months prior to screening or positive drugs of abuse or alcohol test result at the screening visit and/or on admission.
  • Clinically significant electrocardiogram (ECG) rhythm abnormalities.
  • Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.5 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
  • Psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study, including dementia, or patients who are considered to be violent or at suicidal risk by the Investigator.
  • Blood loss of greater than 500 mL within the previous 3 months prior to first dosing.
  • use of any medication from the prohibited concomitant therapies
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): NCT03462043


Locations
Italy
91601
Roma, Italy, 00163
Sponsors and Collaborators
NeuroDerm Ltd.
Investigators
Study Director: Osnat Ehrman NeuroDerm Ltd.
More Information
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Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT03462043     History of Changes
Other Study ID Numbers: ND0612-315
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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
Carbidopa, levodopa drug combination
 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
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists