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

April 27, 2022 updated by: Axovant Sciences Ltd.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Henri Mondor Hospital
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrookes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Long term follow up
Long term follow up of patient's who received ProSavin in previous study
Drug: ProSavin
Long term follow up of patients who received ProSavin in a previous study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the long term safety and tolerability of ProSavin
Time Frame: 10 years
The number and severity of any adverse event
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' responses to ProSavin administration
Time Frame: 10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axovant Sciences Ltd.

Collaborators

Oxford BioMedica

Investigators

  • Principal Investigator: Stephane Palfi, Professor, Henri Mondor University Hospital
  • Principal Investigator: Roger Barker, Dr, Addenbrookes Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 16, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS1/001/09
  • 2009-017253-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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