Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administrati… (NCT07214285) | Clinical Trial Compass
CompletedPhase 1/2
Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine)
France1 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of adverse events
Timeframe: Through study completion, an average of 1 year