Actively Recruiting

Phase 1
Phase 2
All Genders
NCT06831500

Feasibility Study Assessing the Effect of Carbidopa/Levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease.

Led by Julien Bally · Updated on 2026-01-29

36

Participants Needed

2

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is aimed at patients with multi-system atrophy - parkinsonian type (P-MSA) or Parkinson's disease (PD) receiving dopaminergic drugs and suffering from orthostatic hypotension (OH). 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.

CONDITIONS

Official Title

Feasibility Study Assessing the Effect of Carbidopa/Levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease.

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Age over 18 and under 80 years
  • Diagnosis of Multiple System Atrophy - Parkinsonian Type or Parkinson Disease with orthostatic hypotension symptoms
  • Currently receiving dopamine-replacement therapy with levodopa combined with carbidopa or benserazide
Not Eligible

You will not qualify if you...

  • Unable to stand an overnight (at least 12 hours) withdrawal of immediate-release dopamine-replacement therapy
  • Known congestive heart failure grades C and D, NYHA III or IV
  • Dementia or major cognitive impairment associated with MSA-P or PD
  • Mild cognitive impairment preventing informed consent or discernment
  • Current participation in other clinical trials
  • Pregnant or lactating, or planning pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1005

Actively Recruiting

2

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland, 1012

Actively Recruiting

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Research Team

J

Julien BALLY, Dr PD-MER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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