Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07214285
PHASE1/PHASE2

Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine)

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

Summary

Patients included in DIVE I have been receiving this treatment for several years as part of their participation in the study, which is scheduled to end on September 30, 2025. In this context, Lille University Hospital is offering patients still enrolled in DIVE I who wish to do so the opportunity to participate in a new clinical study, "Dive Follow Up," which is a longer-term follow-up study with, if necessary, a dose reduction until the experimental treatment is discontinued and an alternative treatment is put in place. It appears necessary to anticipate the discontinuation of treatment in order to limit as much as possible situations of abrupt discontinuation potentially associated with more severe clinical consequences. Thus, in order to limit the impact of discontinuing this treatment, the sponsor proposes a gradual and individualized reduction in the dose of A-dopamine and, whenever possible, an alternative treatment, in particular the new Scyova treatment. The objective of this study will therefore be to monitor the safety of both long-term A-dopamine treatment and the consequences of discontinuation.

Official title: Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine) DIVE-FOLLOW UP

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2025-10-01

Completion Date

2025-10-30

Last Updated

2025-10-14

Healthy Volunteers

No

Interventions

DRUG

A-DOPAMINE

Intracerebral infusion of anaerobic dopamine.

DEVICE

A-DOPAMINE

Intracerebral infusion of anaerobic dopamine with pump device.

Locations (1)

UHLillle

Lille, Haut de France, France