Parkinson's Disease Clinical Trial
Official title:
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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