Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease

A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.

Patrocinadores

Patrocinador principal: Axovant Sciences Ltd.

Colaborador: Oxford BioMedica

Fuente Axovant Sciences Ltd.
Resumen breve

The study is designed to assess the long term tolerability of ProSavin and whether it is safe and efficacious in patients administered ProSavin from the PS1/001/07 study .

Estado general Active, not recruiting
Fecha de inicio May 2011
Fecha de Terminación May 2022
Fecha de finalización primaria May 2021
Fase Phase 1/Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
To assess the long term safety and tolerability of ProSavin 10 years
Resultado secundario
Medida Periodo de tiempo
Patients' responses to ProSavin administration 10 years
Inscripción 15
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: ProSavin

Descripción: Long term follow up of patients who received ProSavin in a previous study

Etiqueta de grupo de brazo: Long term follow up

Elegibilidad

Criterios:

Inclusion Criteria:

- must have met all inclusion criteria for study PS1/001/07

- willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.

- affiliated with the French social security health care system (Patients enrolled in France only)

- signed and dated written informed consent obtained from the patient and/or the patient's legally acceptable representative, if applicable, in accordance with the local regulations

- must have been treated with ProSavin/Sham

Exclusion Criteria:

-

Género: All

Edad mínima: N/A

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
Henri Mondor Hospital | Paris, France
Addenbrookes Hospital | Cambridge, United Kingdom
Ubicacion Paises

France

United Kingdom

Fecha de verificación

July 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Long term follow up

Tipo: Other

Descripción: Long term follow up of patient's who received ProSavin in previous study

Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Other

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov