RecruitingPhase 1Phase 2NCT07214285

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


Sponsor

University Hospital, Lille

Enrollment

1 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring the long-term safety of a treatment called A-dopamine (anaerobic dopamine), which is delivered directly into the brain's fluid system (intracerebroventricularly), for people with Parkinson's disease who were already enrolled in an earlier study called DIVE I. **You may be eligible if...** - You were previously enrolled in the DIVE I study and are still receiving A-dopamine treatment - You are a beneficiary of the French social security system - You are willing to comply with all study procedures - You have a caregiver present for at least 3 hours per day **You may NOT be eligible if...** - You were not part of the original DIVE I study - You have a serious life-threatening condition unrelated to Parkinson's disease - You take medications that interact dangerously with dopamine (such as MAO-A inhibitors or guanethidine) - You are currently participating in another drug trial - You live alone with no regular caregiver support Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGA-DOPAMINE

Intracerebral infusion of anaerobic dopamine.

DEVICEA-DOPAMINE

Intracerebral infusion of anaerobic dopamine with pump device.


Locations(1)

UHLillle

Lille, Haut de France, France

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NCT07214285


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