Dopaminergic restauratIon by intraVEntriculaire Administration
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
A proof of concept study phase I/IIb with a first phase I of one month of slow titration to
demonstrate the feasibility and the safety and then a phase IIb using a single blind
randomized cross over study (2 periods of 1 month) to demonstrate that cerebroventricular
administration of A-dopamine (dopamine prepared in anaerobia to avoid dopamine oxidation)
affords a better control of motor fluctuations including dyskinesia as compared with
optimized oral treatment in patients with PD at the stage of severe motor complications
related with oral L-dopa using continuous actimetry at home.
In this study it will be expected to: 1) a higher benefit on motor symptoms 2) without
tachyphylaxis, 3) a good ergonomic of the intra-abdominal pump refilled with A-dopamine every
two weeks as compared with the numerous daily L-dopa doses and 4) a good safety profile of
this classical neurosurgical procedure.