Dopaminergic RestauratIon by IntraVEntriculaire Administration (NCT04332276) | Clinical Trial Compass
CompletedPhase 1/2
Dopaminergic RestauratIon by IntraVEntriculaire Administration
France12 participantsStarted 2020-09-18
Plain-language 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: Intracerebroventricular A-dopamine versus optimized oral medical treatment in parkinsonian patients at the stage of severe motor complications (fluctuations and dyskinesias) related to oral L-dopa.
In this study it will be expected to: 1) a higher benefit on motor symptoms 2) without tachyphylaxis, 3) a good ergonomic of the intra-abdominal pump refilled with A-dopamine every two weeks as compared with the numerous daily L-dopa doses and 4) a good safety profile of this classical neurosurgical procedure.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* Over 75 years of age
* Subjects not receiving at least 5 doses per day of oral dopaminergic therapy
* Subject without a prior tr…
What they're measuring
1
Percent Time Over Target
Timeframe: Month 1 through Month 2
2
The number of hours with either perfect control or with a slight slowdown on the 7-day schedule
Timeframe: follow up visits every 6 months until the deadline of September 30, 2023