Feasibility Study Assessing the Effect of Carbidopa/Levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Administration of Carbidopa/levodopa.
- Who it may be relevant to
- Registry conditions: Multi-system Atrophy - Parkinsonian Type, Orthostatic Hypotension, Dysautonomic, Parkinson Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- Feasibility of future large-scale double-blind randomized controlled trial (RCT) [Time frame: From enrollment to the end of study at 5 weeks.]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Switzerland · 2 centers
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne
- Centre Hospitalier Universitaire Vaudois — Lausanne
Identifiers
NCT: NCT06831500 · 2024-02568