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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients included in the DIVE I study still being treated with A-dopamine.

• Social security beneficiary.

• Able to give free and informed consent to participate in the research.

• Patient willing to comply with all study procedures and duration.

• Patient not planning to change their lifestyle (nutritionally, physically, and socially) during their participation in the study.

Locations
Other Locations
France
UHLillle
RECRUITING
Lille
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 1
Treatments
Experimental: A-DOPAMINE
Related Therapeutic Areas
Sponsors
Collaborators: InBrain Pharma
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov