Monocentric, randomized, double-blind study to evaluate the feasibility of conducting a large-scale clinical trial aimed at measuring the effect of the Carbidopa/Levodopa ratio on orthostatic hypotension (OH) in patients with multiple system atrophy – parkinsonian form (MSA-P) or Parkinson's disease (PD). (CARBIDOH)
Résumé de l'étude
This study is aimed at patients with multiple system atrophy – parkinsonian form – (MSA-P) or Parkinson's disease (PD), receiving dopaminergic medications and suffering from orthostatic hypotension (OH). OH is a drop in blood pressure upon standing that can lead to symptoms of dizziness, lightheadedness, blackouts, and can, when severe, lead to fainting. OH is part of the symptoms present in MSA-P and PD. The standard treatment for parkinsonian symptoms such as slowness and stiffness consists of administering antiparkinsonian medications containing dopamine. These dopaminergic medications always contain 1) levodopa (which is the precursor of dopamine) and 2) an enzyme inhibitor, which can 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 medications worsen OH. Through various mechanisms, this worsening of OH is related to both levodopa and the enzyme inhibitor with which it is combined. However, we do not know the respective effects of these two molecules on OH. In this study, we examine how, through the different dosages of the dopaminergic medication under investigation, the Carbidopa/Levodopa ratio affects OH.
(BASEC)
Intervention étudiée
Participants will receive, once a week, in a predetermined random order, and without either they or the study physician knowing the ratio administered at each visit, the 3 different ratios of carbidopa/levodopa, the medication under study:
- 1:2 (100 mg of carbidopa / 200 mg of levodopa) or
- 1:4 (50 mg of carbidopa / 200 mg of levodopa) or
- 1:10 (20 mg of carbidopa / 200 mg of levodopa).
An orthostatic test (measurement of orthostatic hypotension when transitioning from lying down to standing) as well as an evaluation of motor symptoms will be carried out before and after taking each dosage of Carbidopa/Levodopa, the dopaminergic medication under investigation.
(BASEC)
Maladie en cours d'investigation
Orthostatic hypotension (OH) in patients with multiple system atrophy – parkinsonian form (MSA-P) or Parkinson's disease (PD).
(BASEC)
- Patient aged over 18 years and under 80 years. - Patient with multiple system atrophy of parkinsonian type or Parkinson's disease presenting symptoms of orthostatic hypotension. - Patient currently receiving dopaminergic treatment (Levodopa combined with Carbidopa or Benserazide). (BASEC)
Critères d'exclusion
- Patient unable to tolerate a one-night (at least 12 hours) interruption of their immediate-release dopaminergic treatment (and at least 24 hours if extended, delayed, or controlled release). - Patient with dementia (i.e., major cognitive impairment) associated with MSA-P or PD, - Patient with mild cognitive impairment and unable to fully give or understand informed consent, i.e., who does not have full discernment capacity. - Patient with known congestive heart failure, grades C and D, NYHA III and IV. - Current participation in other clinical trials. - Pregnant or breastfeeding woman or wishing to become pregnant. (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
Sponsor: Centre Hospitalier Universitaire Vaudois (CHUV) Sponsor's representative: Dr Julien F. Bally, PD-MER Head of the Movement Disorder Unit Department of Clinical Neurosciences Service of Neurology Centre Hospitalier Universitaire Vaudois (CHUV) Rue du Bugnon 46, 1011 Lausanne, Switzerland
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr Julien Bally
+41 21 314 11 92
julien.bally@clutterchuv.chUnité des mouvements anormaux Service de Neurologie Centre Universitaire Hospitalier Vaudois (CHUV) Rue du Bugnon 46 1011 Lausanne
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
19.02.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06831500 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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. (BASEC)
Titre académique
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) (ICTRP)
Titre public
Feasibility Study Assessing the Effect of Carbidopa/levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease. (ICTRP)
Maladie en cours d'investigation
Multi-system Atrophy - Parkinsonian TypeOrthostatic Hypotension, DysautonomicParkinson Disease (ICTRP)
Intervention étudiée
Drug: Administration of Carbidopa/levodopa (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
1. Informed consent form signed.
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:
1. 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).
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. (ICTRP)
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Critères d'évaluation principaux et secondaires
Feasibility of future large-scale double-blind randomized controlled trial (RCT) (ICTRP)
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
Julien BALLY, Dr PD-MERJulien Bally, Dr. PD MER, julien.bally@chuv.chjulien.bally@chuv.ch, +41 79 556 78 19+41 79 556 78 19 (ICTRP)
ID secondaires
2024-02568 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06831500 (ICTRP)
Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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