Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

Patrocinadores

Patrocinador principal: Novartis

Fuente Novartis
Resumen breve

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.

Estado general Terminated
Fecha de inicio March 2008
Fecha de Terminación May 2009
Fecha de finalización primaria May 2009
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9) Baseline to 15 minutes prior to 2nd dose at Week 8
Resultado secundario
Medida Periodo de tiempo
Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9) Baseline to 15 minutes prior to 2nd dose at Week 8
Inscripción 14
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Carbidopa/levodopa/entacapone

Descripción: Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.

Etiqueta de grupo de brazo: Carbidopa/levodopa/entacapone

Otro nombre: Stalevo®

Tipo de intervención: Drug

Nombre de intervención: Immediate release carbidopa/levodopa

Descripción: Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.

Etiqueta de grupo de brazo: Immediate release carbidopa/levodopa

Elegibilidad

Criterios:

Inclusion Criteria:

- Be aged 30 to 85 years.

- Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.

- Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)

- Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. Also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)

- Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times per day.

Exclusion Criteria:

- Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;

- Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;

- Have unstable Parkinson's Disease requiring frequent booster doses;

- Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33;

- Have a history or current diagnosis of psychotic features according to the investigator;

Other protocol-defined inclusion/exclusion criteria applied to the study.

Género: All

Edad mínima: 30 Years

Edad máxima: 85 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Ubicación
Instalaciones:
Xenoscience, Inc | Phoenix, Arizona, 85004, United States
South Coast Health Center | Aliso Viejo, California, 92656, United States
University of California | Irvine, California, 92697, United States
Coastal Neurological Medical Group, Inc | La Jolla, California, 92037, United States
Georgetown University Hospital | Washington, District of Columbia, 20007, United States
Sunrise Clinical Research, Inc | Hollywood, Florida, 33021, United States
Charlotte Neurological Services | Port Charlotte, Florida, 33952, United States
Cotton O'Neil Clinic | Topeka, Kansas, 66606, United States
University of Maryland School of Medicine | Baltimore, Maryland, 21201, United States
Neurology, Inc | Columbia, Missouri, 65201, United States
Dr. John's Mercy Medical Center | St. Louis, Missouri, 63141, United States
Creighton U Medical Center, Dept of Neurology | Omaha, Nebraska, 68131, United States
Parkinson's Disease & Movement Disorders | Commack, New York, 11725, United States
Central New York Research Corporation | Syracuse, New York, 13210, United States
Neurological Care of Central NY | Syracuse, New York, 13210, United States
Duke University | Durham, North Carolina, 27705, United States
Neurology Associates | Monroeville, Pennsylvania, 15146, United States
University of Pittsburg | Pittsburg, Pennsylvania, 15213, United States
University of Texas Southwestern | Dallas, Texas, 75390, United States
University of Texas Medical School | Houston, Texas, 77030, United States
Scott & White Hospital | Temple, Texas, 76508, United States
Ubicacion Paises

United States

Fecha de verificación

February 2011

Fiesta responsable

Nombre Titulo: External Affairs

Organización: Novartis

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

Etiqueta: Carbidopa/levodopa/entacapone

Tipo: Experimental

Etiqueta: Immediate release carbidopa/levodopa

Tipo: Active Comparator

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov