Long-term safety of intracerebroventricular A-dopamine in people with Parkinson's
Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine) DIVE-FOLLOW UP
This tests whether a gradual, individualized reduction and discontinuation of intracerebroventricular A-dopamine is safe for people with Parkinson's who have been receiving it long-term.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille, Haut de France) |
| Trial ID | NCT07214285 on ClinicalTrials.gov |
What this trial studies
This is a follow-up interventional Phase 1/2 program offered to participants of the DIVE I cohort who remain on intracerebroventricular A-dopamine at Lille University Hospital. Participants will undergo a planned, individualized taper of A-dopamine with clinical monitoring to reduce the risk of abrupt withdrawal, and alternative treatments such as Scyova will be introduced when possible. Safety, tolerability, and clinical status will be followed over the longer term to document outcomes after dose reduction and discontinuation. Enrollment is limited to patients already treated in DIVE I who meet local eligibility and consent requirements.
Who should consider this trial
Good fit: Ideal candidates are patients currently enrolled in DIVE I who are still treated with intracerebroventricular A-dopamine, can provide informed consent, have French social security coverage, and have a caregiver available.
Not a fit: Patients not previously in DIVE I, those with serious life‑threatening comorbidities, those taking prohibited medications, or isolated patients without a caregiver are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could allow patients to stop A-dopamine more safely and reduce the risk of withdrawal-related worsening while transitioning to alternative therapies.
How similar studies have performed: The approach is relatively novel with limited published evidence, though participants from the earlier DIVE I program have received long-term A-dopamine treatment and inform this follow-up.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille, Haut de France
- UHLillle — Lille, Haut de France, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.