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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Tartu University Hospital	Tartu	Estonia
Semmelweis University	Budapest	Hungary
University Of Pecs	Pecs	Hungary
Charite Research Organisation GmbH	Berlin	Germany
Asociacion Instituto De Investigacion Sanitaria Biobizkaia	Barakaldo	Spain
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Astra Kliinik	Tallin	Estonia
Universitatsklinikum Tulln	Tulln An Der Donau	Austria
Parkinson’s Centre of Ospedale CTO	Milan	Italy
Hqasiofg Ughtgxhtzsuqs Dg Lc Pvfrjjiv	Madrid	Spain
Cjvzbtj &jxvwpk Utulvawbxr Mbejkzxx Bnspqd Dpaii oh Nesjreamm	Berlin	Germany
Nirfvtwfqmqmpklkrnvv	Gdansk	Poland
Nwcjopejdy Sca Zsdlht Sv	Siemianowice Slaskie	Poland
Ced Cnifuxjn Sksdsic dw Ncajpjmaaf	Nimes	France
Cuiphk dyigfetkrgkpqvl Canmfpob Hermwnr Ptmnzu Pqal Rwsfkb	Toulouse	France
Ftjuspfm Ajtxbwralchx Myrtw du Tellkqwc	Terrassa	Spain
Nnltchlkfytu Cnlxukw Ang Suf Gtwypzar di Dcj e Rlgxq ddosmwbgs	Salerno	Italy
Drresoiaoisl di nfpcgqzschnyy Sykw dm Niitebeapx Sldso Mdaxs Uucjkjxgvu Hapfzakn	Terni	Italy
Rjhy Ilgdlgfs dmdno Shykwzj Nbjlbsicpngq di Bdpicpz	Bologna	Italy
Avjqltr Ocgsxmcnkoqc Ufktjjqvfamko Phaaqpobduh	Rome	Italy
Pnj Fhcna Cmsdsnfio Gstjvcpi Paoyxos Aytqpza Okvotbwnspp	Tricase	Italy
Slxnj Cvjiam Hivazbpj Nrnwitpkg Dchtfemlba	Trento	Italy
Udkbkdddxv Oe Afytcwh	Edegem	Belgium
Hazyipku Udyvoeziyiwfv Hnmwhhmv Tqrdt y Pnqvat Inzcopyd Cyucob dztrbxufmdijpwmcn (vrdb	Badalona	Spain
Iogpabqo Zoqfpnb Dl Bybzwbwvtbkhnhboi	Oświęcim	Poland
Psgolk fha Njxzwwbacj usd Pmkfmposwaf Dvp Coejemwed Ohwzlnof	Gera	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.09.2023
Belgium	Not recruiting	01.09.2023
Denmark	Not recruiting	01.09.2023
Estonia	Not recruiting	01.09.2023
France	Not recruiting	01.09.2023
Germany	Not recruiting	01.09.2023
Hungary	Not recruiting	01.09.2023
Italy	Not recruiting	01.09.2023
Poland	Not recruiting	01.09.2023
Portugal	Not recruiting	01.09.2023
Spain	Not recruiting	01.09.2023

Trial locations

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.

Investigated diseases:

Orthostatic hypotension

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 ID:

2023-504876-12-00

Protocol code:

0197

NCT ID:

NCT05696717

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?