Clincosm LogoSign in Get a demo

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

Sponsor
NeuroDerm Ltd. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03462043
Collaborator
(none)
0
Enrollment
1
Location
4
Arms
8.7
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Apr 10, 2018
Anticipated Primary Completion Date :
Nov 20, 2018
Anticipated Study Completion Date :
Dec 30, 2018

Arms and Interventions

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

Primary Outcome Measures

  1. Bioavailability [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

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 91601 Roma Italy 00163

Sponsors and Collaborators

  • NeuroDerm Ltd.

Investigators

  • Study Director: Osnat Ehrman, NeuroDerm Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT03462043
Other Study ID Numbers:
  • ND0612-315
First Posted:
Mar 12, 2018
Last Update Posted:
Nov 23, 2018
Last Verified:
Nov 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Nov 23, 2018