NCT00627588

Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin for the Treatment of Bilateral Idiopathic Parkinson's Disease

A Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin®, Administered Using Stereotactic Injection to the Striatum of Patients With Bilateral, Idiopathic Parkinson's Disease.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Oxford BioMedica · Industry
• Sex: All
• Age: 48 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the trial are to assess the safety and efficacy of ProSavin. Patients in the trial will have been diagnosed with Parkinson's disease and will be failing on current treatment with L-DOPA but they will not have progressed to drug-induced dyskinesias. The first stage is an open-label dose escalation to evaluate up to three dose levels of ProSavin in cohorts of three patients each. Following a recommendation by the DMC the study may proceed to the second stage of the trial, a further 12 patients will be recruited to confirm efficacy of the optimal dose in the randomized phase of the study. The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an efficacy assessment at six months after treatment. The secondary objective of the trial is to asses the extent to which patients' current therapy (L-DOPA) can be reduced following administration of ProSavin.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
BIOLOGICAL	ProSavin	ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
BIOLOGICAL	ProSavin	ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-03-03
• Last updated: 2013-05-13

Locations

2 sites across 2 countries: France, United Kingdom