Status:
RECRUITING
Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine)
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
InBrain Pharma
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 Un...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT07214285
Start Date
October 1 2025
End Date
October 30 2025
Last Update
October 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UHLillle
Lille, Haut de France, France, 59000