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Completed

NCT Number: NCT07214285

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UHLillle

Lille, Haut de France, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A-DOPAMINE

Drug

Intracerebral infusion of anaerobic dopamine.

A-DOPAMINE

Device

Intracerebral infusion of anaerobic dopamine with pump device.

Primary outcomes

  1. Frequency of adverse events

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

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • InBrain Pharma

Registry information

Official study title

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

Acronym: DIVE-FOLLOW UP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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