Testing carbidopa and levodopa ratios for low blood pressure on standing
Tests carbidopa and levodopa dose ratios in people with Parkinson disease or MSA-P.
Key facts
- Who runs it
- Julien Bally
- Where
- Lausanne, SwitzerlandSee the 2 sites
- Trial code
- Registry title
- Feasibility Study Assessing the Effect of Carbidopa/Levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease.
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 36 people, planned
- Started
- 18 Jul 2025
- Expected to end
- Nov 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Administration of Carbidopa/levodopa
- Record updated
- 29 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple system atrophy (parkinsonian type) or Parkinson's disease who take dopamine-replacement medicine and have a drop in blood pressure when standing.
- Age
- Over 18 years and under 80 years.
- Sex
- All sexes can join.
- Disease stage
- Multiple system atrophy, parkinsonian type (MSA-P), or Parkinson's disease with symptoms of orthostatic hypotension (a drop in blood pressure when standing). For Parkinson's disease, at least one point on the SCOPA-AUT questions 14, 15 and 16.
- Earlier treatment
- Must currently be taking dopamine-replacement therapy (levodopa with carbidopa or benserazide).
Main reasons for not taking part
- Cannot stop immediate-release dopamine-replacement medicine for at least 12 hours overnight
- Known congestive heart failure, NYHA grade III or IV
- Dementia linked to MSA-P or Parkinson's disease
- Mild cognitive impairment, unable to give or understand informed consent
- Pregnant or breastfeeding, or planning to become pregnant
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Informed consent form signed
- Patient over 18 years and under 80 years of age
- 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)
- Patient currently receiving Dopamine-Replacement Therapy (i.e. Levodopa combined with Carbidopa or Benserazide)
Who cannot take part
- Patient unable to stand an overnight (at least 12 hours) withdrawal of their immediate-release DRT (last extended-, delayed-, or controlled-release dosage must be taken minimum 24 hours prior to the test)
- Patient with known congestive heart failure, grades C and D, NYHA III and IV
- Patient with dementia (i.e. major cognitive impairment) associated to MSA-P or PD,
- Patient with mild cognitive impairment, and unable to provide or understand informed consent, i.e. who does not have full capacity for discernment
- Current participation to other clinical trials
- Pregnant or lactating woman or willing to become pregnant
Where in Switzerland
- Centre Hospitalier Universitaire VaudoisLausanne, SwitzerlandContact: Julien Bally, Dr. PD MERTaking people
- Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, SwitzerlandContact: Matthieu Robitaille, DoctorTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 3 groups in the trial
- Ratio 1:10 i.e. 20 mg Carbidopa / 200 mg LevodopaExisting treatment, for comparison
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Treatment: Administration of Carbidopa/levodopa
- Ratio 1:4 i.e. 50 mg Carbidopa / 200 mg LevodopaExisting treatment, for comparison
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Treatment: Administration of Carbidopa/levodopa
- Ratio 1:2 i.e. 100 mg Carbidopa / 200 mg LevodopaTreatment being tested
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Treatment: Administration of Carbidopa/levodopa
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Testing carbidopa and levodopa ratios for low blood pressure on standingGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 January 2026