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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Recruitment Status : Withdrawn (Decision to change the study design)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 23, 2018
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.

Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date November 23, 2018
Actual Study Start Date  ICMJE April 10, 2018
Estimated Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson
Intervention  ICMJE
  • Combination Product: ND0612
    s.c. infused
  • Combination Product: CLES
    Carbidopa-Levodopa Enteral Suspension.
Study Arms  ICMJE
  • Active Comparator: Sequence A
    Interventions:
    • Combination Product: ND0612
    • Combination Product: CLES
  • Active Comparator: Sequence B
    Interventions:
    • Combination Product: ND0612
    • Combination Product: CLES
  • Active Comparator: Sequence C
    Interventions:
    • Combination Product: ND0612
    • Combination Product: CLES
  • Active Comparator: Sequence D
    Interventions:
    • Combination Product: ND0612
    • Combination Product: CLES
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 20, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
50
Estimated Study Completion Date  ICMJE December 30, 2018
Estimated Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462043
Other Study ID Numbers  ICMJE ND0612-315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NeuroDerm Ltd.
Study Sponsor  ICMJE NeuroDerm Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Osnat Ehrman NeuroDerm Ltd.
PRS Account NeuroDerm Ltd.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP