A Phase 3, Multi-center, Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy
People with a nervous system condition called multiple system atrophy often experience a sudden drop in blood pressure when they stand up. This is known as neurogenic orthostatic hypotension, and it can cause dizziness, light-headedness, and fainting. This Phase 3 clinical trial is testing a study medicine called ampreloxetine to see if it can help keep blood pressure stable and reduce these symptoms. Researchers are also comparing it against a dummy tablet, known as a placebo, and looking at an existing medicine called Gutron (midodrine). The trial measures how well the medicine improves daily life, especially simple tasks like standing or walking for short periods. It also includes a long-term part to check if the medicine remains safe and helpful over time.
Överblick
Vad handlar denna studie om?
Multiple system atrophy (MSA) is a rare condition that affects the nervous system. Over time, it can damage the body's automatic controls, including how it manages blood pressure. Many people with MSA develop a problem called neurogenic orthostatic hypotension. When they stand up from sitting or lying down, their blood pressure drops quickly. This can lead to feeling unsteady, faint, very tired, or even blacking out, which makes everyday life challenging.
This study is testing an investigational medicine called ampreloxetine. The goal is to find out if taking this tablet can help keep blood pressure at a safer level when upright, easing dizziness and unsteadiness. Researchers want to know whether improving these symptoms helps people manage everyday activities, such as standing at the kitchen counter or walking across a room, with greater confidence and comfort.
To make sure the results are accurate, the trial uses a randomised withdrawal design. This means participants first receive the treatment, and later, some continue taking it while others are switched to a dummy pill (placebo) without anyone knowing which is which. Comparing the two groups helps scientists prove whether ampreloxetine is genuinely providing relief. There is also an extension phase to see how well it works over a longer period.
Viktiga punkter
- Testing a new medicine called ampreloxetine for low blood pressure on standing.
- Aimed at adults living with multiple system atrophy (MSA).
- Focuses on reducing dizziness and helping with standing and short walks.
- Involves regular check-ups, questionnaires, and blood pressure monitoring.
- Participation is entirely voluntary and you can withdraw at any time.
Vem kan vara berättigad?
This trial is open to adults aged 18 and over who have been diagnosed with multiple system atrophy and experience dizziness or light-headedness caused by a drop in blood pressure when standing.
Both men and women may be eligible. Because safety is the top priority, people with certain other health conditions, heart problems, or those taking specific medications that could clash with the study drug might not be able to join.
A trial doctor will review your full medical history, run routine health checks, and confirm if taking part is safe and suitable for you.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- I am aged 18 or older.
- I have been diagnosed with multiple system atrophy (MSA).
- I regularly feel faint, dizzy, or light-headed when I stand up.
- I am able to attend regular hospital or clinic appointments for health checks.
- I am willing to take study tablets and answer questions about my daily symptoms.
Vad innebär deltagande?
If you take part, you will attend regular clinic visits over several months. During the main part of the study, lasting around 20 weeks (up to Day 141 and beyond), doctors will monitor your health closely. Assessments include regular blood pressure checks while lying down and standing, physical examinations, and filling out simple questionnaires about your dizziness and daily activities like standing and walking.
You will be given tablets to take by mouth. In some parts of the study, you may receive ampreloxetine, an established treatment called Gutron, or a dummy pill (placebo). After the main testing period, there may be an opportunity to join a long-term extension study to continue receiving treatment and monitoring.
Potentiella risker och fördelar
Platser (11)
- —ObekräftadDanmark
- —ObekräftadSpanien
- —ObekräftadÖsterrike
- —ObekräftadFrankrike
- —ObekräftadTyskland
- —ObekräftadItalien
- —ObekräftadEstland
- —ObekräftadPolen
- —ObekräftadPortugal
- —ObekräftadBelgien
- —ObekräftadUngern
Vanliga frågor
What is neurogenic orthostatic hypotension?
It is a sharp drop in blood pressure that happens when you stand up, caused by changes in your nervous system. It often leads to dizziness or fainting.
What is a Phase 3 clinical trial?
A Phase 3 trial is one of the final stages of research. It tests a medicine in a larger group of people to confirm how well it works and check for side effects.
Vad är en placebo?
A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps scientists see if the real drug is truly making a difference.
Will taking part cost me anything?
No, the study medicine and all tests are provided free of charge. Many trials also offer help with travel expenses to and from the hospital.
Kan jag sluta delta om jag ändrar mig?
Yes, you can leave the study at any time, for any reason, and your regular doctors will continue to look after you as normal.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Intresserad av att delta?
Diskussion
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