Feasibility Study Assessing the Effect of Carbidopa/Levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease.
NCT ID: NCT06831500
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2025-07-18
2026-11-30
Brief Summary
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OH is a drop in blood pressure when standing, which can lead to symptoms of dizziness, lightheadedness, a black veil in front of the eyes and, when severe, can lead to fainting. HO is one of the symptoms present in AMS-P and PD.
The standard treatment for parkinsonian symptoms of slowness and stiffness is the administration of antiparkinsonian drugs containing dopamine. These dopaminergic drugs always contain 1) levodopa (which is the precursor of dopamine) and 2) an enzyme inhibitor, which may be either benserazide (in the case of Madopar® and its generics) or carbidopa (in the case of Sinemet® or Stalevo® and their generics) and whose role is to potentiate the effect of levodopa.
It has long been known that dopaminergic drugs aggravate HO. Through various mechanisms, this worsening of HO is linked as much to levodopa as to the enzyme inhibitor with which it is combined. However, investigators do not know the respective effects of these two molecules on HO.
In this study, investigators examine how the ratio of Carbidopa to levodopa affects HO in the various assays of the dopaminergic drug under study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
As a cross over model study, each patient will receive the 3 ratios of the investigational drug (corresponding to the 3 arms) in a random order.
TREATMENT
DOUBLE
Study Groups
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Ratio 1:10 i.e. 20 mg Carbidopa / 200 mg Levodopa
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Administration of Carbidopa/levodopa
Participants will perform beat-by-beat orthostatic tests (Schellong tests) before and after intake of single doses of carbidopa:levodopa combinations at 3 different ratios
Ratio 1:4 i.e. 50 mg Carbidopa / 200 mg Levodopa
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Administration of Carbidopa/levodopa
Participants will perform beat-by-beat orthostatic tests (Schellong tests) before and after intake of single doses of carbidopa:levodopa combinations at 3 different ratios
Ratio 1:2 i.e. 100 mg Carbidopa / 200 mg Levodopa
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Administration of Carbidopa/levodopa
Participants will perform beat-by-beat orthostatic tests (Schellong tests) before and after intake of single doses of carbidopa:levodopa combinations at 3 different ratios
Interventions
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Administration of Carbidopa/levodopa
Participants will perform beat-by-beat orthostatic tests (Schellong tests) before and after intake of single doses of carbidopa:levodopa combinations at 3 different ratios
Eligibility Criteria
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Inclusion Criteria
2. Patient over 18 years and under 80 years of age.
3. Patient with Multiple System Atrophy- Parkinsonian type (MSA-P) (confirmed by diagnostic criteria for clinically established and clinically probable multiple system atrophy (11); OR Patient with Parkinson Disease (PD) (12) presenting OH symptoms (getting at least one point at the 3 questions - n° 14, 15 and 16 - of the SCOPA-AUT scale that address orthostatic hypotension symptoms).
4. Patient currently receiving Dopamine-Replacement Therapy (i.e. Levodopa combined with Carbidopa or Benserazide).
Exclusion Criteria
2. Patient with known congestive heart failure, grades C and D, NYHA III and IV.
3. Patient with dementia (i.e. major cognitive impairment) associated to MSA-P or PD,
4. Patient with mild cognitive impairment, and unable to provide or understand informed consent, i.e. who does not have full capacity for discernment.
5. Current participation to other clinical trials.
6. Pregnant or lactating woman or willing to become pregnant.
ALL
No
Sponsors
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Julien Bally
OTHER
Responsible Party
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Julien Bally
Principal Investigator and Head of the Movement Disorder Unit in the department of Clinical Neurosciences (CHUV)
Locations
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Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-02568
Identifier Type: -
Identifier Source: org_study_id
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