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

Phase 2RecruitingNCT07214285

University Hospital, Lille1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Patients not included in DIVE I and not treated with A-dopamine. * Presence of another serious condition that is life-threatening in the short or medium term, malnourished or cachectic patients. * Taking treatments containing guanethidine or its relatives, or non-selective and selective monoamine oxidase A inhibitors (iproniazid, moclobemide, toloxatone) * Patients already participating in another therapeutic trial involving the use of an experimental drug other than DIVE I or in an exclusion period * Isolated patients, defined as those without a caregiver present for at least 3 hours/day at the patient's home

Outcomes

Primary Outcomes

Frequency of adverse events

Recording of adverse events at any time. Frequency of adverse events reported by the patient and/or observed by the physician and/or home nurse during clinical examination, ECG, blood pressure, pulse, and standard laboratory tests.

Time frame: Through study completion, an average of 1 year