Your session is about to expire
← Back to Search
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 85 applicable to only early pk cohorts)
Awards & highlights
Study 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 weeks3 visits
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 85 applicable to only early pk cohorts)
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 85 applicable to only early pk cohorts)
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
Cerebrospinal Fluid (CSF) Concentration of TAK-341
Change From Baseline in 11-item UMSARS at Week 52
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Main Cohort: TAK-341 Dose 2Experimental Treatment1 Intervention
Participants will be randomized to receive TAK-341 at a starting Dose 2 at 4 week intervals for up to 52 weeks.
Group II: Early PK Cohort: TAK-341 Dose 1Experimental Treatment1 Intervention
Participants will be randomized to receive TAK-341 at a starting Dose 1 at 4 week intervals for up to 52 weeks.
Group III: Early PK Cohort: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks.
Group IV: Main Cohort: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks.
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,878 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,267 Previous Clinical Trials
288,606,843 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
59 Patients Enrolled for Multiple System Atrophy
Study DirectorStudy DirectorTakeda
1,209 Previous Clinical Trials
489,326 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Main Cohort: TAK-341 Dose 2
- Group 2: Early PK Cohort: TAK-341 Dose 1
- Group 3: Early PK Cohort: Placebo
- Group 4: Main Cohort: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost limit of participants for this clinical experiment?
"Affirmative. Clinicaltrials.gov records show that the clinical trial was first published on November 9th 2022 and has been actively recruiting since then, with a total of 138 individuals sought from 1 location."
Answered by AI
Are there still vacancies available for individuals looking to participate in this investigation?
"Affirmative, the clinicaltrials.gov record states that this medical experiment is currently recruiting volunteers. This trial was initially advertised on November 9th 2022 and has been modified since then; it requires 138 individuals from one hospital to participate in total."
Answered by AI
Has TAK-341 Dose 2 been authorized by the FDA?
"After careful consideration, our team at Power estimated the safety of Main Cohort: TAK-341 Dose 2 to be a 2. This is because this Phase 2 trial has some evidence for safety, but no trials have yet been conducted to evaluate its efficacy."
Answered by AI
Who else is applying?
What site did they apply to?
Quest Research Institute - Alcanza - HyperCore - PPDS
UCLA Neurological Services
NYU Langone Health
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
To hopefully find some treatment for my mother . I've have not tried any medication for this condition.
PatientReceived 2+ prior treatments
Hoping for a successful cure or slowness of progression. I'm looking for trials to slow or change the outcome of my MSA.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Baylor College of Medicine: < 48 hours
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger