Parkinson's Disease
Conditions
Keywords
ProSavin, Gene therapy
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 .
Interventions
DRUGProSavin
Long term follow up of patients who received ProSavin in a previous study
Sponsors
Oxford BioMedica
Axovant Sciences Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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* must have met all inclusion criteria for study PS1/001/07 * willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the long term safety and tolerability of ProSavin | 10 years | The number and severity of any adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France, United Kingdom
Outcome results
None listed