Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01856439
• Other study ID #: PS1/001/09
• Secondary ID: 2009-017253-35
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 2011
• Est. completion date: April 2022

Study information

• Verified date: April 2022
• Source: Sio Gene Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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• willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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:

-

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ProSavin
Long term follow up of patients who received ProSavin in a previous study

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Paris
United Kingdom	Addenbrookes Hospital	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Axovant Sciences Ltd.	Oxford BioMedica

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the long term safety and tolerability of ProSavin	The number and severity of any adverse event	10 years
Secondary	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