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

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axovant Sciences Ltd.; Oxford BioMedica
• Collaborator: Oxford BioMedica

Criteria

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• willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.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

-