Status:
COMPLETED
Dopaminergic RestauratIon by IntraVEntriculaire Administration
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
InBrain Pharma
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Prospective monocentric randomized controlled open-label proof-of-concept study in cross-over of two 1-month periods and a long-term follow-up period not to exceed September 30, 2023, with 2 groups: I...
Detailed Description
Parkinson's disease (PD) is the second most frequent neurodegenerative disorder worldwide. The loss of dopamine through denervation in the striatum as a result of progressive neuronal degeneration in ...
Eligibility Criteria
Inclusion
- Parkinson\'s disease at the stage of L-dopa-induced severe motor and non-motor complications
- Men or women over 18 years old
- Parkinson\'s disease according to MDS criteria
- Severe motor complications including motor fluctuations with at least 2 hours of Off and 1 hour of dyskinesias uncontrolled by optimized oral drug therapy, i.e. with at least 5 doses of L-dopa and the addition or trial of a dopaminergic agonist (if tolerated) per os or by apomorphine pump
- The patient meets the criteria for a second-line invasive treatment such as deep brain stimulation (subthalamic or medial pallidum) or intrajejunal administration of levodopa gel (Duodopa®).
- Patients with a contraindication or who prefer this invasive therapeutic alternative to the other two existing and validated therapies (subthalamic stimulation or Duodopa®) because of its advantages: lower theoretical risk of intracerebroventricular delivery compared to subthalamic stimulation and better ergonomics than Duodopa®, but with the disadvantage of an as yet unproven benefit.
- Social security
- Able to provide free and informed consent to participate in research
- Patient willing to comply with all study procedures and duration
- Patient not planning to change lifestyle (nutritionally, physically or socially) during study participation
Exclusion
- Over 75 years of age
- Subjects not receiving at least 5 doses per day of oral dopaminergic therapy
- Subject without a prior trial of an apomorphine pump (of lower risk); apomorphine pump treatment being a failure or a contraindication or refused by the patient
- Psychiatric history using the semi-structured psychiatric interview with DSM IV MINI: decompensated bipolar illness, psychotic state, current severe depression. Dysthymia and an isolated history of depression are not exclusion criteria.
- Patient with parkinsonian dementia (DSM IV and MDS criteria and MOCA score \< or equal to 22)
- Isolated patient, defined as the absence of a caregiver present at least 3 hours/day in the patient\'s home.
- History of a fall in the last 6 months and/or a score \>1 on items 2.12 (Walking and balance) and/or 3.12 (Postural stability) of the MDS-UPDRS scale
- Presence of another serious pathology threatening short- or medium-term vital prognosis, malnourished or cachectic patient.
- Hemostasis disorders
- Cardiac rhythm disorders and/or heart failure not controlled by treatment
- Uncontrolled blood pressure release
- Breastfeeding and pregnancy
- Women of childbearing age without effective contraception
- Contraindication to general anaesthesia
- Taking treatments containing guanethidine or related compounds or non-selective and selective monoamine oxidase A inhibitors (iproniazid, moclobemide, toloxatone)
- Neurosurgical contraindication (severe cerebral atrophy, brain tumor, infarction or other cerebral pathology, CSF flow disorder)
- Contraindication to abdominal placement of a subcutaneous pump and catheter that impairs healing and transcutaneous filling (e.g. major obesity, skin pathology, etc.).
- Contraindication to MRI (pacemaker, claustrophobia, etc.) and/or intolerance to gadolinium
- Active infectious pathology (including Covid-19)
- Immunologically deficient pathology likely to promote superinfection of equipment
- Patients under guardianship or trusteeship
- Patient already participating in another therapeutic trial using an investigational drug or in an exclusion period
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04332276
Start Date
September 18 2020
End Date
May 6 2024
Last Update
September 25 2024
Active Locations (1)
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1
Hopital Roger Salengro, CHU Lille
Lille, France, 59037