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

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

Patrocinadores

Patrocinador principal: NeuroDerm Ltd.

Fuente NeuroDerm Ltd.
Resumen breve

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

Descripción detallada

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.

Estado general Withdrawn
Fecha de inicio April 10, 2018
Fecha de Terminación December 30, 2018
Fecha de finalización primaria November 20, 2018
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Bioavailability 6-7 days
Condición
Intervención

Tipo de intervención: Combination Product

Nombre de intervención: ND0612

Descripción: s.c. infused

Tipo de intervención: Combination Product

Nombre de intervención: CLES

Descripción: Carbidopa-Levodopa Enteral Suspension.

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 30 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Osnat Ehrman Study Director NeuroDerm Ltd.
Ubicación
Instalaciones: 91601
Ubicacion Paises

Italy

Fecha de verificación

November 2018

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: Sequence A

Tipo: Active Comparator

Etiqueta: Sequence B

Tipo: Active Comparator

Etiqueta: Sequence C

Tipo: Active Comparator

Etiqueta: Sequence D

Tipo: Active Comparator

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov