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)
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
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)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
19.02.2025
(BASEC)
ICTRP Studien-ID
NCT06831500 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Feasibility Study Assessing the Effect of Carbidopa/levodopa Ratio on Orthostatic Hypotension in Multiple System Atrophy - Parkinsonian Type and Parkinson Disease. (ICTRP)
Untersuchte Krankheit(en)
Multi-system Atrophy - Parkinsonian TypeOrthostatic Hypotension, DysautonomicParkinson Disease (ICTRP)
Untersuchte Intervention
Drug: Administration of Carbidopa/levodopa (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Feasibility of future large-scale double-blind randomized controlled trial (RCT) (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
2024-02568 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06831500 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar