RecruitingPhase 1Phase 2NCT06831500

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

A Monocentric, Randomized, Double-blind Study to Assess the Feasibility of Conducting a Full-scale Randomized Controlled Trial (RCT) Assessing the Effect of Carbidopa/Levodopa Ratio on Orthostatic Hypotension (OH) in Multiple System Atrophy - Parkinsonian Type (MSA-P) and Parkinson Disease (PD) Patients (CARBIDOH)


Sponsor

Julien Bally

Enrollment

36 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is examining whether the ratio of two ingredients in a common Parkinson's medication (carbidopa to levodopa) affects a symptom called orthostatic hypotension — a sudden drop in blood pressure when standing up, which can cause dizziness or fainting. The study focuses on patients with Parkinson's disease or a related condition called multiple system atrophy. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with Parkinson's disease or Multiple System Atrophy (Parkinsonian type) - You experience symptoms of low blood pressure when standing (dizziness, lightheadedness) - You are currently taking levodopa combined with carbidopa or benserazide **You may NOT be eligible if...** - You are unable to stop your immediate-release Parkinson's medication overnight for the study assessment - You have other conditions that would make this medication pause unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdministration 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


Locations(2)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

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NCT06831500


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