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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ratio 1:10 i.e. 20 mg Carbidopa / 200 mg Levodopa | Active Comparator | This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order). |
|
| Ratio 1:4 i.e. 50 mg Carbidopa / 200 mg Levodopa | Active Comparator | This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order). |
|
| Ratio 1:2 i.e. 100 mg Carbidopa / 200 mg Levodopa | Experimental | This Carbidopa / Levodopa IMP ratio will be administered as a single dose, orally, at visit 1 or 2 or 3 (random order). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Carbidopa/levodopa | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of future large-scale double-blind randomized controlled trial (RCT) | The primary objective is to investigate the feasibility of conducting a future large-scale double-blind randomized controlled trial (RCT) assessing the effect on orthostatic hypotension (OH) of different dosages of Carbidopa (20, 50 or 100 mg), for a constant Levodopa dose (200 mg) through:
| From enrollment to the end of study at 5 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien BALLY, Dr PD-MER | Contact | +41 79 556 78 19 | julien.bally@chuv.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting | Lausanne | Canton of Vaud | 1005 | Switzerland |
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It's a monocentric, randomized, double-blind study to assess the feasibility of conducting a full-scale randomized controlled trial (RCT).
As a cross over model study, each patient will receive the 3 ratios of the investigational drug (corresponding to the 3 arms) in a random order.
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Double blinded study: Nobody except pharmacists will know the ratios of the investigated product administrated at each visit
| Centre Hospitalier Universitaire Vaudois | Recruiting | Lausanne | Canton of Vaud | 1012 | Switzerland |
|
| ID | Term |
|---|---|
| D012791 | Shy-Drager Syndrome |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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