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

NCT07214285 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 2025_0243
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 1 year

Study Arms (1)

A-DOPAMINE

EXPERIMENTAL

Drug: A-DOPAMINE; Device: A-DOPAMINE

Interventions

A-DOPAMINE DRUG

Intracerebral infusion of anaerobic dopamine.

A-DOPAMINE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Isolated patients, defined as those without a caregiver present for at least 3 hours/day at the patient's home

Sponsors & Collaborators

• University Hospital, Lille: lead
• InBrain Pharma: collaborator

Study Sites (1)

UHLillle

Lille, Haut de France, 59000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 9, 2025
• Study Start: October 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)