TAK-341 for Multiple System Atrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TAK-341 for individuals with multiple system atrophy (MSA), a rare disorder affecting the nervous system that can cause movement and balance issues. The main goal is to evaluate TAK-341's effectiveness after a year, compared to a placebo (a treatment with no active medicine), using a specific rating scale for MSA symptoms. Participants will receive infusions every four weeks and attend regular check-ups. The trial seeks individuals diagnosed with MSA in the last four years who have noticeable symptoms. The study takes place in North America, Europe, and Asia. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that TAK-341 is likely to be safe for humans?
Research shows that TAK-341 is under careful study for its safety and tolerability. Although specific side effects of TAK-341 are not yet available, its progression to a Phase 2 trial indicates some level of safety. This phase typically assesses treatment tolerance and identifies any serious side effects.
Participants in this study receive TAK-341 infusions every four weeks for up to a year. This schedule allows researchers to gather extensive information on side effects and the drug's behavior in the body over time.
If TAK-341 had major safety issues in earlier tests, it likely would not have advanced to this stage. While some uncertainty remains, the trial's progress provides reassurance about TAK-341's safety thus far.12345Why do researchers think this study treatment might be promising for multiple system atrophy?
Unlike the standard care for Multiple System Atrophy, which often involves managing symptoms with medications like levodopa or autonomic agents, TAK-341 is distinctive because it potentially targets the underlying disease mechanisms. Researchers are excited about TAK-341 because it represents a novel approach, possibly addressing the root causes rather than just alleviating symptoms. By administering TAK-341 at regular 4-week intervals, there is hope that it might offer a more sustained and targeted therapeutic effect, which could be a game-changer for those affected by this challenging condition.
What evidence suggests that TAK-341 might be an effective treatment for multiple system atrophy?
Research has shown that TAK-341, which participants in this trial may receive, might help people with multiple system atrophy. This trial will compare TAK-341 with a placebo to assess its effectiveness. Studies are evaluating how well TAK-341 can improve symptoms using a special scale for this condition. Although detailed results are not yet available, the research focuses on how TAK-341 affects the brain and nervous system to alleviate symptoms. Early signs suggest a positive effect, but more data is needed to confirm its efficacy.12345
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 13 intravenous infusions of TAK-341 or placebo every 4 weeks for up to 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- TAK-341
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
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
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