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

A multicentre, open-label extension study to determine the long term safety, tolerability and efficacy of ProSavin® in patients with bilateral, idiopathic Parkinson’s disease

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017253-35-GB

Enrollment

Registered

2010-08-06

Start date

2010-08-20

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with bilateral, idiopathic Parkinson's Disease

Interventions

Product Name: ProSavin Pharmaceutical Form: Suspension for injection INN or Proposed INN: ProSavin

Eligibility

Sex/Gender

All

Inclusion criteria

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 Willing to have their L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant anti-parkinsonian medication 2.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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 ? 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 ? The patients’ responses to ProSavin administration on activity of daily living using the PD Questionnaire 39 (PDQ-39)	—

Measure

Time frame

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 ? 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 ? The patients’ responses to ProSavin administration on activity of daily living using the PD Questionnaire 39 (PDQ-39)

—

Countries

United Kingdom

Contacts

Public ContactEnquiries

Oxford BioMedica (UK) Ltd

enquiries@oxfordbiomedica.co.uk+441865783000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026