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

NCT ID: NCT07214285

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-10-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A-DOPAMINE

Group Type: EXPERIMENTAL

A-DOPAMINE

Intervention Type: DRUG

Intracerebral infusion of anaerobic dopamine.

A-DOPAMINE

Intervention Type: DEVICE

Intracerebral infusion of anaerobic dopamine with pump device.

Interventions

A-DOPAMINE

Intracerebral infusion of anaerobic dopamine.

Intervention Type: DRUG

A-DOPAMINE

Intracerebral infusion of anaerobic dopamine with pump device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InBrain Pharma

UNKNOWN

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UHLillle

Lille, Haut de France, France

Site Status: RECRUITING

Countries

France

Facility Contacts

Caroline MOREAU, MHD, PHD

Role: primary

caroline.moreau@chu-lille.fr

+33320446752

Other Identifiers

2025_0243

Identifier Type: -

Identifier Source: org_study_id