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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856439
Recruitment Status : Terminated (As a result of termination of development of Prosavin, it is no longer possible for Sio to either commence or to continue any related clinical trials.)
First Posted : May 17, 2013
Last Update Posted : May 3, 2022
Sponsor:
Collaborator:
Oxford BioMedica
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )

Study Description
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Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ProSavin Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.
Study Start Date : May 2011
Actual Primary Completion Date : November 2021
Actual Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To assess the long term safety and tolerability of ProSavin [ Time Frame: 10 years ]
    The number and severity of any adverse event


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856439


Locations
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France
Henri Mondor Hospital
Paris, France
United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Sponsors and Collaborators
Axovant Sciences Ltd.
Oxford BioMedica
Investigators
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Principal Investigator: Stephane Palfi, Professor Henri Mondor University Hospital
Principal Investigator: Roger Barker, Dr Addenbrookes Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT01856439    
Other Study ID Numbers: PS1/001/09
2009-017253-35 ( EudraCT Number )
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
ProSavin
Gene therapy
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases