Study on the Effects of TAK-341 for Patients with Multiple System Atrophy

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What is this study about?

This clinical trial is focused on studying a disease called Multiple System Atrophy (MSA). MSA is a rare condition that affects the nervous system, leading to problems with movement, balance, and the function of various body systems. The study is testing a treatment called TAK-341, which is a type of medication known as a human IgG1 lambda monoclonal antibody against alpha-synuclein. This medication is given through an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective and safe TAK-341 is for people with MSA. Participants in the study will receive either the medication or a placebo, which is a substance with no active ingredients. The study will last for about 52 weeks, during which participants will have regular check-ups and assessments to monitor their health and the effects of the treatment. These assessments will include various tests and evaluations to see how the treatment is working and to ensure the safety of the participants.

Throughout the study, participants will be closely monitored by healthcare professionals. The study aims to provide valuable information about the potential benefits and safety of TAK-341 for treating Multiple System Atrophy. This research could help improve the understanding and management of this challenging condition in the future.

1 joining the study

Upon joining the study, the participant will be informed about the procedures, potential benefits, side effects, and risks involved. This information is provided through an informed consent form, which must be signed to confirm understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes evaluating cognitive function, body mass index, and the severity of symptoms related to multiple system atrophy (MSA).

3 treatment administration

The treatment involves the administration of a human igg1 lambda monoclonal antibody against alfa-synuclein or a placebo. This is given as a solution for infusion through intravenous use.

The treatment is administered regularly over a period of 52 weeks. The exact schedule and dosage will be determined by the study protocol.

4 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor the participant’s health and the effects of the treatment. These assessments include clinical evaluations, laboratory tests, and imaging studies.

5 final evaluation

At the end of the 52-week period, a final evaluation will be conducted to assess the overall impact of the treatment. This includes measuring changes in symptoms and any side effects experienced during the study.

Who Can Join the Study?

The person or their legal representative must sign a form showing they understand the study, its experimental nature, possible benefits, risks, and discomforts.
The person must have a MoCA score of 18 or higher. MoCA stands for Montreal Cognitive Assessment, a test to check thinking abilities.
Men who can have children and are sexually active must agree to use a condom during the study and for a certain period after the last dose. They should also not donate sperm during this time.
Women can join if they are not pregnant or breastfeeding and agree to use effective birth control during the study and for a certain period after the last dose.
The person must be at least 40 years old and not staying in a hospital.
The person should be able to attend all study appointments and complete all tests, including brain scans and a procedure called a lumbar puncture.
The person must have a body mass index (BMI) between 18 and 35. BMI is a measure of body fat based on height and weight.
The person must have a diagnosis of possible or probable Multiple System Atrophy (MSA), a condition affecting the nervous system.
The first symptoms of MSA must have started within the last 4 years.
The person should have a life expectancy of at least 3 years, according to the study doctor’s judgment.
The person must have a specific score on a test called UMSARS Part I, which measures symptoms of MSA. This includes scores on swallowing, walking, and falling items.
The person must have a specific score on UMSARS Part IV, which measures disability related to MSA.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of Multiple System Atrophy cannot participate. This is a condition that affects the nervous system.
Participants must be within a certain age range, typically adults and older adults.
Both males and females are eligible, but certain health conditions may exclude participation.
People who are considered part of a vulnerable population may not be eligible. This term refers to groups who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
St. Josef-Hospital	Bochum	Germany
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA	Kassel	Germany
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.	Bonn	Germany
CNS Saude Lda.	Torres Vedras	Portugal
Ospedale San Raffaele S.r.l.	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario De Cruces	Barakaldo	Spain
Roskilde University	Roskilde	Denmark
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Hbbqglrd Ukbeqeuvdypvi Dk Lh Pqabfnmp	Madrid	Spain
Amqqjaqnbo Pcjfjohu Hpatjntt Du Mecwsctsw	Marseille	France
Mzmdage Uazobisrjg Ob Gqox	Graz	Austria
Advqyj Ukgkstouio Hzthpeno	Aarhus	Denmark
Uumrtklidrfqzxiucrszq Mmnrsrqz Arr	Munster	Germany
Kzssgzpi dhl Uevipwnffurm Mgzofaii Ajg	Munich	Germany
Hfsqpacd De Lq Sapix Ctst I Suea Pko	Barcelona	Spain
Hcychony Vdlg dkcqboxl	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	27.10.2022
Denmark	Not recruiting	27.10.2022
France	Not recruiting	27.10.2022
Germany	Not recruiting	27.10.2022
Italy	Not recruiting	27.10.2022
Portugal	Not recruiting	27.10.2022
Spain	Not recruiting	27.10.2022

Trial locations

Investigated drugs:

TAK-341 is an investigational medication being studied for its potential to treat Multiple System Atrophy, a rare neurological disorder. The trial aims to assess how effective, safe, and tolerable this medication is when given intravenously. Researchers are also studying how the body processes and responds to TAK-341 over time.

Multiple System Atrophy – Multiple System Atrophy is a rare neurological disorder that affects the body’s involuntary functions, including blood pressure, breathing, bladder function, and motor control. It is characterized by a combination of symptoms similar to Parkinson’s disease, such as slow movement, muscle rigidity, and poor balance. As the disease progresses, individuals may experience increasing difficulty with movement and coordination, as well as problems with autonomic functions like blood pressure regulation and bladder control. The condition is caused by the degeneration of nerve cells in specific areas of the brain, leading to a decline in motor and autonomic functions. Symptoms typically begin in adulthood and worsen over time, affecting daily activities and quality of life.

Trial ID:

2023-509876-40-00

Protocol code:

TAK-341-2001

NCT ID:

NCT05526391

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of TAK-341 for Patients with Multiple System Atrophy

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