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

University Hospital, Lille

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Parkinson Disease

Treatments

Device: A-DOPAMINE

Study type

Interventional

Funder types

Other

Identifiers

NCT07214285

2025_0243

Details and patient eligibility

About

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.

Enrollment

1 estimated patient

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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