Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

Patrocinadores

Patrocinador principal: Loma Linda University

Fuente Loma Linda University
Resumen breve

This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.

Descripción detallada

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease.

2. Age > 40 years.

3. willingness and ability to comply with the study requirements and give informed consent.

Estado general Terminated
Fecha de inicio February 2002
Fecha de Terminación January 2009
Fecha de finalización primaria January 2009
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in Duration of Dyskinesia. 2 weeks
Resultado secundario
Medida Periodo de tiempo
Percent Change in "on" Time 4 weeks
Change in Dose of Anti-parkinsonian Medications 7 weeks
Inscripción 2
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: sildenafil

Descripción: sildenafil 50mg BID for 2 weeks

Etiqueta de grupo de brazo: Viagra

Otro nombre: Viagra

Tipo de intervención: Drug

Nombre de intervención: Placebo

Etiqueta de grupo de brazo: Placebo comparator

Elegibilidad

Criterios:

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.

2. Presence of drug-induced dyskinesias

3. Age>40 years.

4. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

1. Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.

2. History of stereotaxic brain surgery.

3. Clinical history of dementia.

4. Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.

5. History of major hematological, renal, or hepatic abnormalities.

6. Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.

7. History of stroke within the last 6 months.

8. Abnormal EKG consistent with cardiac ischemia.

9. Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).

10. Malignant hypertension or SBP . 180 or <90, or DBP .110 or <50.

11. History of priapism.

12. Known history of retinitis pigmentosa.

13. Positive pregnancy test.

14. History of bleeding disorder.

15. Patients with active peptic ulcer disease associated with bleeding.

16. Unwillingness to use adequate contraceptive methods if of childbearing potential.

17. Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.

18. Use of Viagra or any experimental drugs within 30 days of screening visit.

Género: All

Edad mínima: 18 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
David M. Swope, MD Principal Investigator Loma Linda University
Ubicación
Instalaciones: Loma Linda University
Ubicacion Paises

United States

Fecha de verificación

March 2018

Fiesta responsable

Tipo: Sponsor

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

Etiqueta: Viagra

Tipo: Experimental

Descripción: subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Etiqueta: Placebo comparator

Tipo: Placebo Comparator

Descripción: subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Treatment

Enmascaramiento: Triple (Participant, Care Provider, Investigator)

Fuente: ClinicalTrials.gov