TAK-341 for Multiple System Atrophy

Recruiting in Palo Alto (17 mi)

+59 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Takeda

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My first symptoms of MSA appeared less than 4 years ago.

You have symptoms and deficits related to MSA, as measured by the UMSARS scale.

You have been diagnosed with a possible or probable case of MSA using specific diagnostic criteria.

Exclusion Criteria

The participant has any contraindication to study procedures.

Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement.

I have not been in a study for PD or MSA involving α-synuclein immunization or had immunoglobulin G therapy in the last 6 months.

+1 more

Participant Groups

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.

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.