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
NCT ID: NCT03462043
Last Updated: 2018-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2018-04-10
2018-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence A
ND0612
s.c. infused
CLES
Carbidopa-Levodopa Enteral Suspension.
Sequence B
ND0612
s.c. infused
CLES
Carbidopa-Levodopa Enteral Suspension.
Sequence C
ND0612
s.c. infused
CLES
Carbidopa-Levodopa Enteral Suspension.
Sequence D
ND0612
s.c. infused
CLES
Carbidopa-Levodopa Enteral Suspension.
Interventions
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ND0612
s.c. infused
CLES
Carbidopa-Levodopa Enteral Suspension.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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NeuroDerm Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Osnat Ehrman
Role: STUDY_DIRECTOR
NeuroDerm Ltd.
Locations
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91601
Roma, , Italy
Countries
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Other Identifiers
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ND0612-315
Identifier Type: -
Identifier Source: org_study_id
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