Status:
TERMINATED
Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease
Lead Sponsor:
Axovant Sciences Ltd.
Collaborating Sponsors:
Oxford BioMedica
Conditions:
Parkinson's Disease
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
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 .
Eligibility Criteria
Inclusion
- 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- willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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
- \-
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01856439
Start Date
May 1 2011
End Date
April 1 2022
Last Update
May 3 2022
Active Locations (2)
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1
Henri Mondor Hospital
Paris, France
2
Addenbrookes Hospital
Cambridge, United Kingdom