Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease
- Registration Number
- NCT01856439
- Lead Sponsor
- Axovant Sciences Ltd.
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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- willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long term follow up ProSavin Long term follow up of patient's who received ProSavin in previous study
- Primary Outcome Measures
Name Time Method To assess the long term safety and tolerability of ProSavin 10 years The number and severity of any adverse event
- Secondary Outcome Measures
Name Time Method Patients' responses to ProSavin administration 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.
Trial Locations
- Locations (2)
Henri Mondor Hospital
🇫🇷Paris, France
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Henri Mondor Hospital🇫🇷Paris, France