We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. )

Tracking Information
First Submitted Date  ICMJE May 14, 2013
First Posted Date  ICMJE May 17, 2013
Last Update Posted Date May 3, 2022
Study Start Date  ICMJE May 2011
Actual Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)		 To assess the long term safety and tolerability of ProSavin [ Time Frame: 10 years ]
The number and severity of any adverse event
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease
Official Title  ICMJE A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.
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 .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: ProSavin
Long term follow up of patients who received ProSavin in a previous study
Study Arms  ICMJE Long term follow up
Long term follow up of patient's who received ProSavin in previous study
Intervention: Drug: ProSavin
Publications * Palfi S, Gurruchaga JM, Ralph GS, Lepetit H, Lavisse S, Buttery PC, Watts C, Miskin J, Kelleher M, Deeley S, Iwamuro H, Lefaucheur JP, Thiriez C, Fenelon G, Lucas C, Brugieres P, Gabriel I, Abhay K, Drouot X, Tani N, Kas A, Ghaleh B, Le Corvoisier P, Dolphin P, Breen DP, Mason S, Guzman NV, Mazarakis ND, Radcliffe PA, Harrop R, Kingsman SM, Rascol O, Naylor S, Barker RA, Hantraye P, Remy P, Cesaro P, Mitrophanous KA. Long-term safety and tolerability of ProSavin, a lentiviral vector-based gene therapy for Parkinson's disease: a dose escalation, open-label, phase 1/2 trial. Lancet. 2014 Mar 29;383(9923):1138-46. doi: 10.1016/S0140-6736(13)61939-X. Epub 2014 Jan 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 16, 2013)		 15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2022
Actual Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01856439
Other Study ID Numbers  ICMJE PS1/001/09
2009-017253-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sio Gene Therapies ( Axovant Sciences Ltd. )
Original Responsible Party Oxford BioMedica
Current Study Sponsor  ICMJE Axovant Sciences Ltd.
Original Study Sponsor  ICMJE Oxford BioMedica
Collaborators  ICMJE Oxford BioMedica
Investigators  ICMJE
Principal Investigator: Stephane Palfi, Professor Henri Mondor University Hospital
Principal Investigator: Roger Barker, Dr Addenbrookes Hospital
PRS Account Sio Gene Therapies
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP