This trial is active, not recruiting.

Condition parkinson's disease
Treatment prosavin
Phase phase 1/phase 2
Sponsor Oxford BioMedica
Start date May 2011
End date May 2021
Trial size 15 participants
Trial identifier NCT01856439, 2009-017253-35, PS1/001/09


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 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Long term follow up of patient's who received ProSavin in previous study
Long term follow up of patients who received ProSavin in a previous study

Primary Outcomes

To assess the long term safety and tolerability of ProSavin
time frame: 10 years

Secondary Outcomes

Patients' responses to ProSavin administration
time frame: 10 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - must have met all inclusion criteria for study PS1/001/07 - willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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: -

Additional Information

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.
Principal investigator Stephane Palfi, Professor
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Oxford BioMedica.