ong-term study of patients who received ProSavin in the PS1/001/07 clinical trial.

Conditions: Patients with bilateral, idiopathic Parkinson's Disease
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2009-017253-35-GB

Lead Sponsor: Oxford BioMedica (UK) Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 27

Inclusion Criteria

Patients must first have met all the inclusion criterion of Study PS1/001/07, however the following criteria will be reconfirmed for this study:
1.Willing to have their L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant anti-parkinsonian medication
2.Affiliated with the French social security health care system (Patients enrolled in France only)
3.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
4.Patients must have been treated with ProSavin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

None

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long term safety and tolerability of ProSavin;Secondary Objective: To assess the long term clinical efficacy following ProSavin administration;Primary end point(s): The number and severity of any adverse events ;Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: from 36 months up to year 10;Secondary end point(s): ? The patients’ responses to ProSavin administration by assessment using, the Unified PD Rating Scale (UPDRS) Part III<br>? The patients’ responses to ProSavin administration by evaluating the percentage of time during the waking day that the patient is in the OFF” state as assessed by patient diaries<br>? The patients’ responses to ProSavin administration on activity of daily living using the PD Questionnaire 39 (PDQ-39)