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

Phase 2TerminatedNCT01856439

Axovant Sciences Ltd.15 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

ProSavinDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * must have met all inclusion criteria for study PS1/001/07 * willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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: \-

Locations (2)

Henri Mondor Hospital

Paris, France

Addenbrookes Hospital

Cambridge, United Kingdom

Outcomes

Primary Outcomes

To assess the long term safety and tolerability of ProSavin

The number and severity of any adverse event

Time frame: 10 years

Secondary Outcomes

Patients' responses to ProSavin administration

Assessed using Unified Parkinson's Disease Rating Score(UPDRS) Part III, evaluating percentage of time during waking day that patient is in the "off" state through patient diaries and activities of daily living using PDQ-39 at 36 months post administration.

Time frame: 10 years

Data from ClinicalTrials.gov

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