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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01856439
First received: May 14, 2013
Last updated: June 9, 2014
Last verified: June 2014

May 14, 2013
June 9, 2014
May 2011
May 2021   (final data collection date for primary outcome measure)
To assess the long term safety and tolerability of ProSavin [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
The number and severity of any adverse event
Same as current
Complete list of historical versions of study NCT01856439 on ClinicalTrials.gov Archive Site
Patients' responses to ProSavin administration [ Time Frame: 10 years ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
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.

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 .

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Parkinson's Disease
Drug: ProSavin
Long term follow up of patients who received ProSavin in a previous study
Long term follow up
Long term follow up of patient's who received ProSavin in previous study
Intervention: Drug: ProSavin
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, Brugières 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.
 
Active, not recruiting
15
May 2022
May 2021   (final data collection date for primary outcome measure)

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:

-

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   France
 
NCT01856439
PS1/001/09, 2009-017253-35
Yes
Oxford BioMedica
Oxford BioMedica
Not Provided
Principal Investigator: Stephane Palfi, Professor Henri Mondor Hospital
Principal Investigator: Roger Barker, Dr Addenbrookes Hospital
Oxford BioMedica
June 2014

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