Ended Therapeutic exploratory (Phase II) Multiple System Atrophy

A Study to evaluate Efficacy, Safety, Tolerability and Effects of TAK-341 in the human body in patients with Multiple System Atrophy

EU CTIS ID: 2023-509876-40-00

What this study is testing

To evaluate the efficacy of TAK-341 versus placebo, as measured by the change from baseline to Week 52 on UMSARS Part I, minus the sexual function item, with collapse of the normal and mild ratings on each item.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

The subject (or, when applicable, the subject's legally acceptable representative) signs an informed (e)consent form indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts (additionally for subjects in Germany or Austria: the subject has been informed of the nature, significance, and implications of the clinical study and is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications) in the opinion of the investigator. If the subject becomes incompetent over the course of the study, a legally authorized court-appointed representative or an appointed agent in health matters (ie, legally acceptable representative) will need to be identified and the subject will need to provide assent, in accordance withthe local regulations, guidelines, and the IRB/IEC to provide informed consent on the subject's behalf to continue in the clinical study).
Subject has a MoCA ≥18. Additionally, subject has sufficiently intact cognition to complete study and follow study instructions, per investigator´s judgment.
A male subject who is nonsterilized (fertile) and sexually active with a female partner of childbearing potential is eligible to participate if he agrees to use a barrier method of contraception (ie, condom with or without spermicide) from the signing of informed (e)consent throughout the study and for 90 days plus 5 half-lives (total of 190 days) after the last dose. In addition, they must be advised not to donate sperm during this period. The female partner of a male subject should also be advised to use a highly effective method of contraception.
Female subjects are eligible to participate if (a) they are not pregnant or nursing and (b) they are of nonchildbearing potential or agree to use highly effective contraception from the signing of informed consent throughout the study and for 30 days plus 5 half-lives (total of 130 days) after the last dose of study drug.
The subject is an outpatient of either sex, at least 40 years old, at the time of consent.
Subjects must, in the opinion of the investigator, be able to participate in all scheduled evaluations, likely to be compliant, and likely to complete all required tests, including neuroimaging brain scans and lumbar punctures.

You likely can't join if

1. The subject has serious or unstable clinically significant illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune (eg, multiple sclerosis), hematologic, or other major disease, which, in the judgment of the investigator, is poorly controlled or otherwise likely to deteriorate, compromises the subject's safety or ability to complete the study, or compromises the interpretation of the study results.
10. Contraindication to lumbar puncture (as assessed by the Investigator).
11. The subject has hypersensitivity to TAK-341 or any excipients used in its formulation.
12.Subject has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment, or basal cell carcinoma; these subjects may be included after approval by the sponsor or designee).
13. Any clinically significant abnormality at screening or between screening and randomization in physical examination findings, vital signs, electrocardiograms (ECGs), or clinical laboratory test results
14. Presence of any of contraindications to MRI as assessed by the Investigator.

See the full eligibility criteria

Who can join

The subject (or, when applicable, the subject's legally acceptable representative) signs an informed (e)consent form indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts (additionally for subjects in Germany or Austria: the subject has been informed of the nature, significance, and implications of the clinical study and is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications) in the opinion of the investigator. If the subject becomes incompetent over the course of the study, a legally authorized court-appointed representative or an appointed agent in health matters (ie, legally acceptable representative) will need to be identified and the subject will need to provide assent, in accordance withthe local regulations, guidelines, and the IRB/IEC to provide informed consent on the subject's behalf to continue in the clinical study).
Subject has a MoCA ≥18. Additionally, subject has sufficiently intact cognition to complete study and follow study instructions, per investigator´s judgment.
A male subject who is nonsterilized (fertile) and sexually active with a female partner of childbearing potential is eligible to participate if he agrees to use a barrier method of contraception (ie, condom with or without spermicide) from the signing of informed (e)consent throughout the study and for 90 days plus 5 half-lives (total of 190 days) after the last dose. In addition, they must be advised not to donate sperm during this period. The female partner of a male subject should also be advised to use a highly effective method of contraception.
Female subjects are eligible to participate if (a) they are not pregnant or nursing and (b) they are of nonchildbearing potential or agree to use highly effective contraception from the signing of informed consent throughout the study and for 30 days plus 5 half-lives (total of 130 days) after the last dose of study drug.
The subject is an outpatient of either sex, at least 40 years old, at the time of consent.
Subjects must, in the opinion of the investigator, be able to participate in all scheduled evaluations, likely to be compliant, and likely to complete all required tests, including neuroimaging brain scans and lumbar punctures.
The subject has a body mass index ≥18 and ≤35 kg/m2 at screening.
The subject has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.
The subject's onset of first MSA symptoms (including parkinsonism, cerebellar symptoms, orthostatic or urinary symptoms) occurred ≤4 years before screening as assessed by the investigator.
The subject's anticipated life expectancy is ≥3 years, per investigator judgment.
The subject has an UMSARS Part I score of ≤21 (excluding Item #11, sexual function) at screening visit (Visit 1), and additionally has: a) Severity score ≤2 on the swallowing item (#2) at screening visit (Visit 1). b) Severity score ≤2 on the ambulation item (#7) at screening visit (Visit 1). c) Severity score ≤2 on the falling item (#8) at screening visit (Visit 1).
The subject has an UMSARS Part IV disability score ≤3 at screening visit (Visit 1).

What rules you out

1. The subject has serious or unstable clinically significant illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune (eg, multiple sclerosis), hematologic, or other major disease, which, in the judgment of the investigator, is poorly controlled or otherwise likely to deteriorate, compromises the subject's safety or ability to complete the study, or compromises the interpretation of the study results.
10. Contraindication to lumbar puncture (as assessed by the Investigator).
11. The subject has hypersensitivity to TAK-341 or any excipients used in its formulation.
12.Subject has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment, or basal cell carcinoma; these subjects may be included after approval by the sponsor or designee).
13. Any clinically significant abnormality at screening or between screening and randomization in physical examination findings, vital signs, electrocardiograms (ECGs), or clinical laboratory test results
14. Presence of any of contraindications to MRI as assessed by the Investigator.
15. Ophthalmic abnormalities
16.The subject has any of the following at the screening visit: estimated glomerular filtration rate (determined with the Chronic Kidney Disease Epidemiology Collaboration equation) <50 mL/min; QT interval with Fridericia correction method >450 ms for male subjects and >470 ms for female subjects; a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >1.5 × the upper limit of normal (ULN).
17. "Clinically significant vital sign abnormalities at screening, defined as (a) systolic blood pressure ≥160 mm Hg, (b) diastolic blood pressure ≥90 mm Hg (blood pressure assessed with the subject at rest in the seated position; may be repeated up to 3 times), or (c) pulse rate <45 or >100 beats per minute (subject at rest in the seated position; may be repeated up to 3 times).
18.Positive hepatitis B surface antigen test result, known or suspected active hepatitis C infection, or known history of HIV infection.
19.Brain MRI showing clinically significant evidence of malignant, ischemic, hemorrhagic, demyelinating, structural, or degenerative brain disease (other than MSA) that may confound diagnosis or compromise subject safety during the study, or the subject has findings that compromise the safety of lumbar puncture.
2.The subject has medical problems (neurological, visual, orthopedic, psychiatric) that may significantly interfere with completion of the studyor interpretation of study endpoints or may confound diagnosis.
20. Current blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory tests of coagulation.
21.Poor venous access
22.Participation in another study investigating active or passive immunization against αSYN for Parkinson disease or MSA.
23.The subject has had immunoglobulin G therapy for any reason within6 months before screening.
24.Participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment)
25.Any investigational compound being received that may not have completely washed out before the screening visit.
26.Positive pregnancy test result at screening.
27.The subject is an immediate family member, is a study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study
28.Donation of 400 mL or more of his or her blood volume within 90 days before the start of the screening visit.
29.Austrian participants without capacity of consent (ie, ability to understand and process information relevant to making an informed, voluntary decision to participate in research).
3.The subject has a disorder that is likely to interfere with drug disposition and elimination.
4. In the opinion of the investigator, the subject has a diagnosis of depression or other psychiatric disorder, as defined by DSM-5, AND this disorder is poorly controlled and of sufficient severity to interfere with completion of the study or interpretation of the endpoints.
5.The subject is considered by the investigator to be a imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide within the past year before screening.
6. The subject has a history of alcohol or substance use disorder (except tobacco use disorder), as defined by the DSM-5, within 1 year before screening or between screening and randomization
7.The subject has positive finding on an alcohol or illicit drug screen.
8. The subject has undergone surgery for the treatment of MSA (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation).
9. History of epilepsy or seizures, except self-limited febrile childhood seizures.

The study team makes the final eligibility decision.

Where it's taking place

United States
Japan
United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Japan; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.