Actively Recruiting
Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine)
Led by University Hospital, Lille · Updated on 2025-10-14
1
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
I
InBrain Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UHLillle
Lille, Haut de France, France, 59000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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