NCT07214285CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 25 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- University Hospital, Lille
- Diseases
- Parkinson disease
- NCT number
- NCT07214285
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 1
- From 1 Oct 2025 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients not included in DIVE I and not treated with A-dopamine.
- 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
Other illness
- Presence of another serious condition that is life-threatening in the short or medium term, malnourished or cachectic patients.
Other
- Isolated patients, defined as those without a caregiver present for at least 3 hours/day at the patient's home
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UHLillle Coordinator of this site? Confirm its status | Lille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.