TAK-341 for Multiple System Atrophy

Recruiting at 59 trial locations

Overseen By Jason Aldred

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Disqualifiers: Confounding diagnosis, Immunoglobulin G therapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 52 weeks

159 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What makes the drug TAK-341 unique for treating multiple system atrophy?

TAK-341 is unique because it is being investigated as a potential disease-modifying therapy for multiple system atrophy, a condition for which current treatments mainly focus on relieving symptoms rather than altering the disease course. ^{1 2 3 4 5}

Research Team

Study Director

Principal Investigator

Takeda

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive 13 intravenous infusions of TAK-341 or placebo every 4 weeks for up to 52 weeks

52 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 12 weeks

1 visit (in-person)

Treatment Details

Interventions

• Placebo
• TAK-341

Trial Overview 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.

Participant Groups

Group I: Main Cohort: TAK-341 Experimental Treatment 1 Intervention

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

Group II: Early PK Cohort: TAK-341 Experimental Treatment 1 Intervention

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

Group III: Early PK Cohort: Placebo Placebo Group 1 Intervention

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

Group IV: Main Cohort: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

A cross-sectional study involving 225 patients with multiple system atrophy (MSA) utilized the unified multiple system atrophy rating scale (UMSARS) to assess the disease, highlighting the need for sensitive outcome measures for future trials.

The Japan MSA research consortium (JAMSAC) aims to conduct longitudinal studies to better understand the natural history of MSA and to develop effective therapeutic trials, emphasizing the importance of appropriate trial design and inclusion criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic trial design issues for future disease-modifying therapy of multiple system atrophy]. Ichikawa, Y., Goto, J., Nakahara, Y., et al.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Therapeutic trial design issues for future disease-modifying therapy of multiple system atrophy]. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Present and future of disease-modifying therapies in multiple system atrophy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Widespread microglial activation in multiple system atrophy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Incidence and prevalence of multiple system atrophy: a nationwide study in Iceland. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Towards translational therapies for multiple system atrophy. [2022]