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COMPLETED
NCT04332276
PHASE1/PHASE2

Dopaminergic restauratIon by intraVEntriculaire Administration

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

Summary

Prospective monocentric randomized controlled open-label proof-of-concept study in cross-over of two 1-month periods and a long-term follow-up period not to exceed September 30, 2023, with 2 groups: Intracerebroventricular A-dopamine versus optimized oral medical treatment in parkinsonian patients at the stage of severe motor complications (fluctuations and dyskinesias) related to oral L-dopa. 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.

Official title: A New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine (Dopamine Stored in Anaerobia) for Severe Motor Fluctuations in Parkinson's Disease?

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2020-09-18

Completion Date

2024-05-06

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

A-dopamine

During the phase 1 (titration), it is planned to increase dopamine by maximum 0.25 mg per hour over the daytime period, which corresponds to a maximum increase of 4.5 mg per day (based on the 18 hours of the daytime period, since nocturnal needs are much less important). Then, depending on tolerance and efficacy, conservative titration will be continued for a target dose of 30-87 mg per day. During the phase 2 (efficacy), the treatment will be maintained at the minimum effective dose, planned between 30 and 87 mg per day, for 30 days.

DRUG

optimized oral treatment

The patient will received his usual dopaminergic treatment.

Locations (1)

Hopital Roger Salengro, CHU Lille

Lille, France