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Other

TAK-341 for Multiple System Atrophy

Phase 2
Recruiting
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, 29, 57, 85, 169, 253, 337; at multiple timepoints (up to 24 hours) post-dose on days 1, 57, 85, 169, 337; anytime once on days 365, 427 or at early termination (day 57 applicable to only early pk cohorts)
Awards & highlights

Summary

This trial will test a drug (TAK-341) to see if it works over 52 weeks for people with Multiple System Atrophy, with infusions and assessments every 4 weeks.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~pre-dose on days 1, 29, 57, 85, 169, 253, 337; at multiple timepoints (up to 24 hours) post-dose on days 1, 57, 85, 169, 337; anytime once on days 365, 427 or at early termination (day 57 applicable to only early pk cohorts)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on days 1, 29, 57, 85, 169, 253, 337; at multiple timepoints (up to 24 hours) post-dose on days 1, 57, 85, 169, 337; anytime once on days 365, 427 or at early termination (day 57 applicable to only early pk cohorts) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in a Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I at Week 52
Secondary outcome measures
AUCτ: Area Under the Concentration-time Curve During a Dosing Interval in Serum for TAK-341
CSF Concentration of TAK-341
Change From Baseline in 11-item UMSARS at Week 52
+11 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.

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.

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,213 Previous Clinical Trials
4,187,015 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,461 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
59 Patients Enrolled for Multiple System Atrophy
Study DirectorStudy DirectorTakeda
1,230 Previous Clinical Trials
500,952 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
~52 spots leftby Aug 2025