NCT07214285

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	A-DOPAMINE	Intracerebral infusion of anaerobic dopamine.
DEVICE	A-DOPAMINE	Intracerebral infusion of anaerobic dopamine with pump device.

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2025-10-09
• Last updated: 2025-10-14

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study