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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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
RECRUITING
Lausanne
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Contact Information
Primary
Julien BALLY, Dr PD-MER
julien.bally@chuv.ch
+41 79 556 78 19
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2026-11
Participants
Target number of participants: 36
Treatments
Active_comparator: Ratio 1:10 i.e. 20 mg Carbidopa / 200 mg Levodopa
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Active_comparator: Ratio 1:4 i.e. 50 mg Carbidopa / 200 mg Levodopa
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Experimental: Ratio 1:2 i.e. 100 mg Carbidopa / 200 mg Levodopa
This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order).
Sponsors
Leads: Julien Bally

This content was sourced from clinicaltrials.gov