Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

Patrocinadores

Patrocinador principal: EMD Serono

Fuente EMD Serono
Resumen breve

The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).

Estado general Completed
Fecha de inicio September 30, 2004
Fecha de Terminación February 28, 2006
Fecha de finalización primaria February 28, 2006
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 Week 12
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24 Week 24
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12 Baseline, Week 12
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24 Baseline, Week 24
Inscripción 506
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Sarizotan

Descripción: Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.

Etiqueta de grupo de brazo: Sarizotan

Tipo de intervención: Drug

Nombre de intervención: Placebo

Descripción: Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

Inclusion Criteria:

- The subject is an out-patient.

- The subject presents with a diagnosis of idiopathic Parkinson's disease.

- Prior therapy with all registered Parkinsonian medication is allowed.

Exclusion Criteria:

- (For female subjects) The subject is pregnant or lactating.

- The subject is participating in another clinical study or has done so within the past 30 days.

- The subject has received neurosurgical intervention related to PD.

- The subject has relevant renal impairment.

- The subject has relevant hepatic impairment.

- The subject is suffering from any dementia or psychiatric illness.

- The subject has a history of allergic asthma.

Género: All

Edad mínima: 30 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Medical Responsible Study Director EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Ubicación
Instalaciones:
| Birmingham, Alabama, 35233, United States
| Huntsville, Alabama, 35801, United States
| La Jolla, California, 92037, United States
| Oxnard, California, 93030, United States
| Sacramento, California, 95817, United States
| Englewood, Colorado, 80113, United States
| Danbury, Connecticut, 06810, United States
| Farmington, Connecticut, 06030-1840, United States
| Jacksonville, Florida, 32209, United States
| Jacksonville, Florida, 32216, United States
| Maitland, Florida, 32751, United States
| Saint Petersburg, Florida, 33703, United States
| Decatur, Georgia, 30033, United States
| Chicago, Illinois, 60611-3078, United States
| Springfield, Illinois, 62702, United States
| Des Moines, Iowa, 50309, United States
| New Orleans, Louisiana, 70112, United States
| Scarborough, Maine, 04074, United States
| Boston, Massachusetts, 02215, United States
| Southfield, Michigan, 48034, United States
| Edison, New Jersey, 08818, United States
| New Hyde Park, New York, 11040, United States
| New Hyde Park, New York, 12401, United States
| New York, New York, 10016, United States
| Durham, North Carolina, 27705, United States
| Oklahoma City, Oklahoma, 73104, United States
| Pittsburgh, Pennsylvania, 15213, United States
| Brentwood, Tennessee, 37027, United States
| South Ogden, Utah, 84403, United States
| Spokane, Washington, 99204, United States
| Milwaukee, Wisconsin, 53233, United States
Ubicacion Paises

United States

Fecha de verificación

July 2018

Fiesta responsable

Tipo: Sponsor

Palabras clave
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Sarizotan

Tipo: Experimental

Etiqueta: Placebo

Tipo: Placebo Comparator

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov