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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Neurogenic Orthostatic Hypotension (nOH), which often affects people with Multiple System Atrophy (MSA). nOH is a condition where a person's blood pressure drops significantly when they stand up, leading to dizziness or fainting. The study will evaluate the effectiveness and long-term benefits of a medication called Ampreloxetine, which is a selective norepinephrine reuptake inhibitor. This medication is being compared to a placebo to see how well it works in treating symptoms of nOH in people with MSA.

The trial will involve participants taking Ampreloxetine tablets over a period of time. Initially, there will be an open-label phase lasting 12 weeks, where all participants will receive the medication. This will be followed by a double-blind phase lasting 8 weeks, where participants will be randomly assigned to continue with either the medication or a placebo. The purpose of this study is to assess how well Ampreloxetine can improve symptoms and maintain its effects over time.

In addition to Ampreloxetine, the study will also involve the use of Gutron (midodrine hydrochloride), which is another medication used to treat low blood pressure. Participants will take these medications orally in tablet form. The study aims to provide valuable information on the potential benefits of these treatments for individuals with nOH and MSA, helping to improve their quality of life by managing symptoms more effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Open-label period

    The trial begins with an open-label period lasting 12 weeks. During this time, you will take ampreloxetine tablets orally. The dosage and frequency will be determined by the study team based on your specific needs and health status.

    You will be monitored regularly to assess how you are responding to the medication. This includes checking your blood pressure and other health indicators to ensure your safety and the effectiveness of the treatment.

  2. Step 2

    Randomized withdrawal period

    After completing the open-label period, you will enter an 8-week randomized withdrawal period. During this phase, you may either continue receiving ampreloxetine or be switched to a placebo, which is a tablet that looks like the medication but does not contain the active ingredient.

    Neither you nor the study team will know whether you are receiving the medication or the placebo. This is to ensure that the results are not influenced by expectations about the treatment.

  3. Step 3

    Long-term extension

    Following the randomized withdrawal period, you may have the option to participate in a long-term extension of the study. This phase is designed to gather more information about the long-term effects and safety of ampreloxetine.

    Your participation in this phase will be discussed with you, and you will receive detailed information about what it involves, including any changes to your medication regimen.

  4. Step 4

    Regular assessments

    Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the treatment. These assessments may include physical exams, blood tests, and questionnaires about your symptoms and daily activities.

    The primary goal of these assessments is to evaluate changes in your condition, particularly focusing on symptoms related to neurogenic orthostatic hypotension, such as dizziness or lightheadedness when standing.

  5. Step 5

    End of trial

    At the end of the trial, you will have a final assessment to review your overall health and any changes in your condition. The study team will discuss the results with you and provide guidance on next steps for your treatment.

    You will also have the opportunity to ask any questions you may have about the trial and your participation in it.

Who can join the trial?

11 criteria

  • Participant must be male or female and at least 30 years old.
  • Participant must be willing and able to provide signed and dated written informed consent to participate before starting any study-related procedures.
  • Participant must be able to communicate well with the study team, understand the study expectations, and follow the study procedures and rules.
  • Participant must have a diagnosis of possible or probable MSA (Multiple System Atrophy) of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to specific criteria.
  • Participant must have a diagnosis of possible or probable MSA confirmed by the Enrollment Steering Committee.
  • Participant must meet the diagnostic criteria of nOH (neurogenic orthostatic hypotension), which means having 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 from lying down, as determined by a test.
  • Participant must score 4 or less on a specific test called UMSARS Part IV at the first visit (Screening).
  • Participant must score at least a 4 on the OHSA item 1 at the second visit (Day 1).
  • Participant must be willing to not take any prohibited medications during the study.
  • If the participant is female, she must not be pregnant, breastfeeding, or planning a pregnancy during the study. A woman who can have children must have a negative pregnancy test at screening.
  • During the study and for 30 days after the last dose of the study drug, females who can have children or males capable of fathering children must agree to use highly effective birth control methods or agree to abstain from sexual intercourse.

Who cannot join the trial?

10 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who are unable to comply with the study procedures.
  • Patients with a known allergy to the study medication or its ingredients.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients with a history of certain heart conditions.
  • Patients who are taking medications that might interfere with the study drug.
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Investigated drugs

Ampreloxetine is a medication being studied for its potential to help people with a condition called symptomatic neurogenic orthostatic hypotension (nOH), which can occur in individuals with multiple system atrophy (MSA). This condition causes a significant drop in blood pressure when a person stands up, leading to dizziness or fainting. Ampreloxetine is designed to help stabilize blood pressure and reduce these symptoms, improving the quality of life for those affected. The trial aims to see how effective and long-lasting the benefits of ampreloxetine are compared to a placebo. Participants will first take the medication for 12 weeks, followed by an 8-week period where they may continue with the medication or switch to a placebo without knowing which one they are receiving.

What is already known about the treatment

Ampreloxetine – Ampreloxetine is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating neurogenic orthostatic hypotension, a condition where blood pressure drops significantly when standing up, causing dizziness or fainting. The medication works by inhibiting the reuptake of norepinephrine, a chemical in the brain that helps regulate blood pressure, thereby increasing its levels and improving blood flow. Ampreloxetine is classified as a norepinephrine reuptake inhibitor and is being evaluated for its potential benefits in people with multiple system atrophy who experience this type of low blood pressure.

Investigated diseases

Neurogenic Orthostatic Hypotension – Neurogenic Orthostatic Hypotension is a condition characterized by a significant drop in blood pressure when a person stands up from a sitting or lying position. This drop in blood pressure is due to a malfunction in the autonomic nervous system, which fails to regulate blood pressure properly. As a result, individuals may experience dizziness, lightheadedness, or even fainting upon standing. The condition is often associated with neurodegenerative disorders such as Multiple System Atrophy or Parkinson's disease. Over time, the symptoms can become more pronounced, affecting daily activities that involve standing or walking. The progression of the disease can vary, with some individuals experiencing more severe symptoms than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504876-12-00Protocol code0197Estimated enrolment108 patientsSponsorTheravance Biopharma Ireland Limited

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