RecruitingPhase 1Phase 2NCT07214285

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

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


Sponsor

University Hospital, Lille

Enrollment

1 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interventions

DRUGA-DOPAMINE

Intracerebral infusion of anaerobic dopamine.

DEVICEA-DOPAMINE

Intracerebral infusion of anaerobic dopamine with pump device.


Locations(1)

UHLillle

Lille, Haut de France, France

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NCT07214285


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