Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease

Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study

Patrocinadores

Patrocinador principal: Sandoz

Fuente Sandoz
Resumen breve

The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.

Descripción detallada

PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment

SECONDARY OBJECTIVE

- Evaluate the improvement for Depression which is one of the Nonmotor symptoms

- Evaluate the improvement of clinical symptoms between two groups

- Evaluate the improvement of Quality of Life between two groups

Estado general Completed
Fecha de inicio February 2012
Fecha de Terminación May 23, 2016
Fecha de finalización primaria May 23, 2016
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
K-NMSS 24 weeks
Resultado secundario
Medida Periodo de tiempo
K-MADRS 24 weeks
UPDRS I/II/III 24 weeks
K-PDQ39 24 weeks
Inscripción 121
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: pramipexole

Descripción: pramipexole

Etiqueta de grupo de brazo: pramipexole

Otro nombre: Sandoz Pramipexole

Tipo de intervención: Drug

Nombre de intervención: Bromocriptine

Descripción: bromocriptine

Etiqueta de grupo de brazo: Bromocriptine

Otro nombre: Parlodel tab

Elegibilidad

Criterios:

Inclusion Criteria:

- Parkinson's disease patients in accordance with UK Queensquare Brain Bank

- modified Hoehn & Yahr stage <3

- Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.

Exclusion Criteria:

- K-MMSE<24

- History of drug-induced Parkinsonism

- secondary parkinsonism

- History of schizophrenia or hallucination

- Requirement of treatment with anti-depressants due to depressive disorder

- Pregnant and/or breeding women

- Renal inadequacy

Género: All

Edad mínima: 30 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Seongbeom Koh, MD Principal Investigator Korea University Guro Hospital
Ubicación
Instalaciones:
Korea University Ansan Hospital | Ansan, Korea, Republic of
Inje University Busan Paik Hospital | Busan, Korea, Republic of
Youngnam University Hospital | Daegu, Korea, Republic of
Kangwon Nat'l University Hospital | Kangwon, Korea, Republic of
Inje university Sanggye Paik Hospital | Seoul, Korea, Republic of
Korea University Anam Hospital | Seoul, Korea, Republic of
Korea University Guro Hospital | Seoul, Korea, Republic of
Ubicacion Paises

Korea, Republic of

Fecha de verificación

September 2017

Fiesta responsable

Tipo: Sponsor

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

Etiqueta: pramipexole

Tipo: Experimental

Descripción: dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks

Etiqueta: Bromocriptine

Tipo: Active Comparator

Descripción: bromocriptine dosage form: white round tablet

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov