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2 clinical trials in this condition
Study on the Effects of Fludrocortisone in Treating Neurogenic Orthostatic Hypotension in Patients
FranceStudy on Ampreloxetine and Midodrine Hydrochloride for Treating Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy
AustriaIn short
Currently, there are 2 clinical trials investigating treatments for orthostatic hypotension, a condition where blood pressure drops significantly upon standing, causing dizziness or fainting. These trials are being conducted across multiple countries in Europe and are testing medications aimed at helping the body maintain stable blood pressure when moving from lying down to standing up.
This trial is examining the effectiveness of fludrocortisone in treating neurogenic orthostatic hypotension, a condition where blood pressure drops significantly upon standing due to problems with the nervous system. The study aims to evaluate how well this medication can help manage symptoms like dizziness and fainting over a four-week treatment period.
Main inclusion criteria: To participate, you must be over 18 years old and have a confirmed diagnosis of neurogenic orthostatic hypotension with symptoms. This means experiencing a drop in blood pressure of more than 20 mmHg (systolic) or 10 mmHg (diastolic) within 3 minutes of standing up. You must also have a score different from 0 in at least one of the six items on the Orthostatic Hypotension Questionnaire. Additionally, you need to have an underlying condition such as Parkinson's disease, multisystemic atrophy, Lewy bodies dementia, isolated progressive dysautonomia, diabetes, or kidney failure. The condition must persist despite previous treatments including non-medicinal measures like compression stockings and medications like midodrine.
Main exclusion criteria: You cannot participate if you do not have neurogenic orthostatic hypotension, are outside the specified age range, are unwilling or unable to follow study procedures, or have other medical conditions that might interfere with the study. Pregnant or breastfeeding women, those taking medications that could interfere with the study, and individuals who have recently participated in another clinical trial are also excluded.
Focus and goal: The trial will monitor blood pressure changes when you move from lying down to standing up. Participants will complete the Orthostatic Hypotension Questionnaire and a quality of life assessment to evaluate symptom improvement. The study will also track any side effects or unusual blood pressure changes to understand the medication's safety profile.
Investigational drug: Fludrocortisone (marketed as Flucortac) is taken as a 50 microgram tablet once daily. This medication works by helping your body retain salt, which increases blood volume and helps maintain blood pressure when standing up. It belongs to a class of medications called corticosteroids, which mimic hormones produced by the adrenal glands.
This trial is studying ampreloxetine, a medication being tested to help people with neurogenic orthostatic hypotension who also have Multiple System Atrophy. The study has two phases: an initial 12-week period where all participants receive the medication, followed by an 8-week period where participants are randomly assigned to either continue with the medication or receive a placebo.
Main inclusion criteria: You must be at least 30 years old and able to provide informed consent. You need a diagnosis of possible or probable Multiple System Atrophy of either the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C), confirmed by the Enrollment Steering Committee. Your condition must meet the diagnostic criteria for neurogenic orthostatic hypotension, meaning a sustained drop in blood pressure of at least 20 mmHg (systolic) or 10 mmHg (diastolic) within 3 minutes of standing or being tilted up 60 degrees. You must score 4 or less on a specific test called UMSARS Part IV at screening and at least a 4 on the OHSA item 1 at the second visit. Women who can have children must have a negative pregnancy test, and both men and women must agree to use effective birth control during the study and for 30 days after.
Main exclusion criteria: You cannot participate if you have any other serious medical condition that might interfere with the study, are pregnant or breastfeeding, have participated in another clinical trial within the last 30 days, or have a history of drug or alcohol abuse within the past year. Other exclusions include inability to comply with study procedures, known allergy to the study medication or its ingredients, uncontrolled high blood pressure, severe liver or kidney disease, history of certain heart conditions, or taking medications that might interfere with the study drug.
Focus and goal: The trial aims to assess how effectively ampreloxetine can stabilize blood pressure and reduce symptoms such as dizziness or lightheadedness when standing. The study will evaluate both the immediate benefits during the open-label phase and the long-term sustainability of these effects during the randomized withdrawal phase. Regular assessments will include physical exams, blood tests, and questionnaires about your symptoms and daily activities.
Investigational drug: Ampreloxetine is taken orally as a tablet. It works by inhibiting the reuptake of norepinephrine, a chemical in the brain that helps regulate blood pressure. By increasing norepinephrine levels, the medication aims to improve blood flow and help maintain stable blood pressure when standing up. The trial is also studying this medication in combination with midodrine hydrochloride (Gutron), another medication used to treat low blood pressure.
Two clinical trials are currently recruiting patients with neurogenic orthostatic hypotension across Europe. One trial is specific to France and focuses on fludrocortisone, a medication that helps the body retain salt to increase blood volume. The second trial is more widely distributed across ten European countries including Austria, Spain, Germany, France, Poland, Italy, Portugal, Estonia, Belgium, and Hungary, and is testing ampreloxetine, which works by affecting brain chemicals that regulate blood pressure.
Both studies specifically target neurogenic orthostatic hypotension, where the blood pressure drop is caused by nervous system problems rather than other causes. The French trial is open to patients with various underlying conditions including Parkinson's disease and diabetes, while the multi-country trial focuses specifically on patients with Multiple System Atrophy. Both trials require that participants have tried previous treatments without sufficient improvement, indicating these studies are exploring options for people who need additional help managing their symptoms.
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