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NCT04332276CompletedPhase 1/2

Dopaminergic restauratIon by intraVEntriculaire Administration

A New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine (Dopamine Stored in Anaerobia) for Severe Motor Fluctuations in Parkinson's Disease?

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
12 (actual)
First submitted
25 Mar 2020
Start date
18 Sept 2020
Primary completion date
6 May 2024
Lead sponsor
University Hospital, Lille
NCT number
NCT04332276
EU CT number
2024-517566-42-00
EudraCT number
2020-000155-12

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 12
  • From 18 Sept 2020 to the primary completion date, 6 May 2024
  • 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

  • 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
  • Taking treatments containing guanethidine or related compounds or non-selective and selective monoamine oxidase A inhibitors (iproniazid, moclobemide, toloxatone)
  • Patient already participating in another therapeutic trial using an investigational drug or in an exclusion period

Other illness

  • 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)
  • 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
  • Hemostasis disorders
  • Cardiac rhythm disorders and/or heart failure not controlled by treatment
  • Neurosurgical contraindication (severe cerebral atrophy, brain tumor, infarction or other cerebral pathology, CSF flow disorder)
  • Active infectious pathology (including Covid-19)

Age

  • Over 75 years of age
  • Women of childbearing age without effective contraception

Other

  • Isolated patient, defined as the absence of a caregiver present at least 3 hours/day in the patient\'s home.
  • Presence of another serious pathology threatening short- or medium-term vital prognosis, malnourished or cachectic patient.
  • Uncontrolled blood pressure release
  • Breastfeeding and pregnancy
  • Contraindication to general anaesthesia
  • 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
  • Immunologically deficient pathology likely to promote superinfection of equipment
  • Patients under guardianship or trusteeship

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire De Lille
Coordinator of this site? Confirm its status
Lille CedexFranceCompleted

This page is information, not medical advice. Discuss any trial with your doctor.