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Ampreloxetine

Clinical trials are studying Ampreloxetine in people with multiple system atrophy and symptomatic neurogenic orthostatic hypotension. These studies aim to evaluate how well it works and how long the benefit lasts, compared with placebo and an active comparator. The main focus is on symptom improvement and patient-reported outcomes.

Table of contents

Trial overview

The available trial is a Phase 3 study of Ampreloxetine in people with multiple system atrophy and symptomatic neurogenic orthostatic hypotension (nOH).[1] It is an interventional study, which means participants receive study treatment so researchers can compare results between groups.[1]

The study is authorised and plans to enroll 108 participants.[1] Its brief summary says the goal is to evaluate the efficacy and durability of Ampreloxetine compared with placebo over an open-label period followed by a double-blind randomized withdrawal period.[1]

Who the trial is for

This trial targets participants with MSA, a disease that affects the nervous system, and who also have symptomatic nOH.[1] The data provided here do not list all eligibility rules, but the main population is clear from the study title and summary.[1]

Symptomatic nOH means the blood pressure drop when standing is causing symptoms, such as feeling faint or dizzy.[1] The study is therefore focused on people whose day-to-day life is affected by this blood pressure problem.[1]

How the study is designed

The study includes a 12-week open-label period followed by an 8-week double-blind randomized withdrawal period.[1] In an open-label period, everyone knows which treatment is being given.[1] In a double-blind period, neither the participant nor the researchers know who is receiving which treatment, which helps make the comparison fair.[1]

The trial also compares Ampreloxetine with placebo, and the intervention list includes an active comparator, Gutron® Tabletten 2.5 mg, shown in the source data.[1] A placebo is a look-alike treatment without the active study drug, while an active comparator is another treatment used for comparison.[1]

What the trial measures

The main endpoint is the change in the OHSA composite score at Week 8 during the double-blind randomized withdrawal period.[1] An endpoint is the main result researchers use to judge whether a treatment works.[1]

OHSA is a symptom score for orthostatic hypotension, so this outcome reflects how the participant feels and functions, not only a blood pressure reading.[1] The brief summary also states that the study is looking at both efficacy and durability, meaning how well the treatment works and how long the effect lasts.[1]

Key study details

The trial ID is NCT05696717.[1] The study phase is Phase 3 and the status is Authorised.[1]

The intervention list in the source includes Ampreloxetine tablets, oral Ampreloxetine 10 mg, and Gutron® Tabletten 2.5 mg as the comparator treatment.[1] The source does not provide more details on dosing schedules beyond what is listed in the trial record.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05696717 Phase 3 Neurogenic Orthostatic Hypotension in participants with Multiple System Atrophy Authorised 108

FAQ

  • What is being studied in the Ampreloxetine trials? The trials are studying whether Ampreloxetine can improve symptoms of neurogenic orthostatic hypotension in people with multiple system atrophy. They also look at how durable the benefit is over time.
  • Who can take part in these trials? The main target group is participants with multiple system atrophy and symptomatic neurogenic orthostatic hypotension. The trial data do not list more detailed entry rules here.
  • What phase is the Ampreloxetine study? The study is in Phase 3. This means it is a later-stage trial that tests how well the treatment works in a larger group of participants.
  • What condition is the trial focused on? The trial focuses on neurogenic orthostatic hypotension, often shortened to nOH. This is a drop in blood pressure when standing up, caused by a problem with the nerves that control blood pressure.
  • What outcome is the study measuring? The main outcome is the change in the OHSA composite score at Week 8 during the double-blind randomized withdrawal period. This score measures symptoms of orthostatic hypotension from the participant's point of view.

Ongoing Clinical Trials on Ampreloxetine

  • Study on Ampreloxetine and Midodrine Hydrochloride for Treating Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Denmark Estonia France Germany +5

Glossary

  • Multiple system atrophy (MSA): A serious nervous system disease that can affect movement, balance, and body functions such as blood pressure control.
  • Neurogenic orthostatic hypotension (nOH): A fall in blood pressure when a person stands up, caused by nerve-related problems. It can lead to dizziness, lightheadedness, or fainting.
  • Symptomatic: Having noticeable signs or complaints. In this trial, it means the blood pressure problem is causing symptoms.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and continues to check safety in a larger group.
  • Interventional study: A study where participants receive a treatment or comparison treatment so researchers can measure the effect.
  • Placebo: A look-alike treatment with no active study drug. It is used to compare results fairly.
  • Active comparator: A treatment already in use that is compared with the study drug.
  • Open-label period: A study period when participants and researchers know what treatment is being given.
  • Double-blind period: A study period when neither the participant nor the researchers know who is receiving which treatment.
  • Randomized withdrawal: A study design where people who first receive the treatment are later assigned by chance to continue it or switch to another option, so researchers can see if the benefit lasts.
  • OHSA composite score: A combined symptom score used to measure how severe orthostatic hypotension symptoms are.

References