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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017253-35 | EudraCT Number |
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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.
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| Name | Class |
|---|---|
| Oxford BioMedica | INDUSTRY |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long term follow up | Other | Long term follow up of patient's who received ProSavin in previous study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProSavin | Drug | Long term follow up of patients who received ProSavin in a previous study |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long term safety and tolerability of ProSavin | The number and severity of any adverse event | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' responses to ProSavin administration | 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. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Stephane Palfi, Professor | Henri Mondor University Hospital | Principal Investigator |
| Roger Barker, Dr | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Paris | France | ||||
| Addenbrookes Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24412048 | Derived | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Cambridge |
| United Kingdom |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |