A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients

A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD

Patrocinadores

Patrocinador principal: NeuroDerm Ltd.

Colaborador: Michael J. Fox Foundation for Parkinson's Research

Fuente NeuroDerm Ltd.
Resumen breve

An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/ infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if continuous delivery of levodopa and carbidopa can provide reduced variability in plasma concentration; to test and compare the PK profile of high and low concentrations of CD; to assess preliminary efficacy.

Estado general Completed
Fecha de inicio August 2014
Fecha de Terminación January 2016
Fecha de finalización primaria December 2014
Fase Phase 1/Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Adverse events frequency Up to 6 weeks
LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax. Days 1, 2, 3 and 4
Tolerability: Number of patients who discontinued due to adverse events Up to 6 weeks
Inscripción 16
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Levodopa and carbidopa SC solution

Descripción: Levodopa and carbidopa SC solution

Etiqueta de grupo de brazo: ND0612

Otro nombre: ND0612

Tipo de intervención: Drug

Nombre de intervención: Oral levodopa and carbidopa

Descripción: Oral levodopa and carbidopa

Etiqueta de grupo de brazo: Oral levodopa and carbidopa

Elegibilidad

Criterios:

Inclusion Criteria:

1. Male and female PD patients of any race aged 30 to 80 years

2. PD diagnosis consistent with the UK PD Society Brain Bank criteria.

3. Stable doses of anti PD drugs for at least 30 days

4. PD patients with well-defined morning "OFF" and a good response to LD

5. MMSE score > 26

6. No clinically significant medical, psychiatric or laboratory abnormalities

Exclusion Criteria:

1. Atypical or secondary Parkinsonism.

2. Acute psychosis or hallucinations.

3. Subjects treated with neuroleptics

4. History of melanoma or significant skin disorders.

5. Prior neurosurgical procedure for PD.

6. Patients with a history of drug abuse or alcoholism

7. Clinically significant ECG abnormalities.

8. Renal or liver dysfunction

9. Subjects who have participated in another clinical study within 30 days

Género: All

Edad mínima: 30 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Ubicación
Instalaciones:
Henry Ford West Bloomfield Hospital | West Bloomfield, Michigan, 48034, United States
Hadassah Medical Center | Jerusalem, Israel
Tel Aviv Medical Center | Tel Aviv, Israel
Ubicacion Paises

Israel

United States

Fecha de verificación

December 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: ND0612

Tipo: Experimental

Descripción: Levodopa and carbidopa SC solution

Etiqueta: Oral levodopa and carbidopa

Tipo: Active Comparator

Descripción: Oral levodopa and carbidopa

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Other

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov