What side effects are associated with this type of intervention?

Common treatments for Multiple System Atrophy (MSA) often include medications to manage symptoms such as autonomic dysfunction, motor impairments, and parkinsonism. Side effects of these treatments can vary but often include nausea, dizziness, orthostatic hypotension, and gastrointestinal issues. For investigational drugs like TAK-341, which involve intravenous infusions, potential side effects may include infusion-related reactions such as headaches, fever, chills, and local site reactions. It is important for patients to discuss the specific side effects of any treatment with their healthcare provider.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of Multiple System Atrophy (MSA). Treatment primarily focuses on managing symptoms, such as autonomic dysfunction and motor impairments, using medications like fludrocortisone, midodrine, and levodopa. TAK-341, an investigational drug, is being studied for its potential to address the underlying disease mechanisms in MSA, which represents a novel approach compared to the symptomatic treatments currently available.

What other types of research exist?

Promising novel alternatives to TAK-341 for Multiple System Atrophy patients include BIIB092, an anti-tau monoclonal antibody, which has shown safety and potential efficacy in progressive supranuclear palsy, a related neurodegenerative condition. Additionally, SM07883, a DYRK1A inhibitor, has demonstrated reduction in tau pathology and neuroinflammation in Alzheimer's disease models, suggesting potential applicability to MSA. These therapies are still under investigation but represent potential options for MSA treatment in the near future.

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TAK-341 for Multiple System Atrophy

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose on days 1, 85 (applicable to only early pk cohorts), and 365

Summary

This trial tests TAK-341 in patients with multiple system atrophy (MSA). It aims to see if TAK-341 can improve or slow down MSA symptoms over several months. The study will measure changes in symptoms.

Who is the study for?

This trial is for individuals diagnosed with possible or probable Multiple System Atrophy (MSA) within the last 4 years, as per specific criteria. They should show MSA symptoms measured by a special scale. People can't join if they have conditions that may risk their safety, have been in certain other MSA studies recently, or received immunization against α-synuclein.

What is being tested?

The study tests TAK-341's effectiveness over a year on people with MSA using an assessment scale. Participants will randomly receive either TAK-341 or a placebo through intravenous infusions every four weeks and undergo regular health checks.

What are the potential side effects?

While the potential side effects of TAK-341 are not detailed here, typical clinical trial risks include reactions at the infusion site, general discomforts like headaches or nausea, and any unique adverse effects related to the drug being tested.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose on days 1, 85 (applicable to only early pk cohorts), and 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose on days 1, 85 (applicable to only early pk cohorts), and 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on days 1, 85 (applicable to only early pk cohorts), and 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in a Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I at Week 52

Secondary study objectives

CSF Concentration of TAK-341

Change From Baseline in 11-item UMSARS at Week 52

Change From Baseline in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) Total Score

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Main Cohort: TAK-341Experimental Treatment1 Intervention

Participants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks.

Group II: Early PK Cohort: TAK-341Experimental Treatment1 Intervention

Participants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks.

Group III: Early PK Cohort: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo at 4-week intervals for up to 52 weeks.

Group IV: Main Cohort: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo at 4-week intervals for up to 52 weeks.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

TAK-341 is an investigational drug administered via intravenous infusions, aimed at treating Multiple System Atrophy (MSA). While specific details about TAK-341's mechanism of action are not provided, it is likely designed to target neurodegenerative processes similar to other treatments under investigation for MSA. Common treatments for MSA often focus on managing symptoms and may include medications that address autonomic dysfunction, motor symptoms, and neuroprotective strategies. Understanding these mechanisms is crucial for MSA patients as it helps in tailoring treatments that can potentially slow disease progression, improve quality of life, and manage the complex array of symptoms associated with MSA.

Pharmacokinetics and efficacy of PT302, a sustained-release Exenatide formulation, in a murine model of mild traumatic brain injury.Laquinimod in the treatment of multiple sclerosis: a review of the data so far.Parkinson risk in idiopathic REM sleep behavior disorder: preparing for neuroprotective trials.

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Who is running the clinical trial?

TakedaLead Sponsor

1,234 Previous Clinical Trials

4,147,833 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,378 Previous Clinical Trials

288,738,759 Total Patients Enrolled

1 Trials studying Multiple System Atrophy

59 Patients Enrolled for Multiple System Atrophy

Study DirectorStudy DirectorTakeda

1,268 Previous Clinical Trials

503,687 Total Patients Enrolled

Media Library

TAK-341 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05526391 — Phase 2

Multiple System Atrophy Research Study Groups: Early PK Cohort: TAK-341, Main Cohort: TAK-341, Early PK Cohort: Placebo, Main Cohort: Placebo

Multiple System Atrophy Clinical Trial 2023: TAK-341 Highlights & Side Effects. Trial Name: NCT05526391 — Phase 2

TAK-341 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05526391 — Phase 2

~45 spots leftby Jul 2025

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